[Summary text]
Study design: Randomized controlled trial, single center, three arms
Study grouping: Parallel group
Baseline Characteristics
Overall
Melatonin (3 mg group)
Melatonin (10 mg group)
Placebo
Included criteria: The study enrolled children aged 8 to 18 years if they had PPCS and a >10-point increase in their total symptom score on the Post Concussion Symptom Inventory (PCSI) postinjury when compared with their preinjury score (assessed at enrollment)
Excluded criteria: Children were ineligible if they had a significant medical or psychiatric history, a previous concussion within the last 3 months, persistent symptoms after a previous concussion, or a more severe TBI previously. Other exclusions included lactose intolerance, use of neuroactive drugs, and inability to complete questionnaires
Pretreatment: None
Intervention Characteristics
Intervention 1
Intervention 2
Control
Alvorlige skadevirkninger (SAE) n,N EoT
Ikke alvorlige skadevirkninger (AE) n,N. EoT
Frafald n,N
Indsovningstid, mean SD EoT
Total sovetid, mean SD, EoT
Antal opvågninger, mean SD, EoT
Objective measurements: Actigraph (Actiwatch-2 (Philips Respironics)
Sponsorship source: Funded by the Canadian Institutes of Health Research (grant 293375), the Alberta Children’s Hospital Research Institute, and the University of Calgary
Country: Australien / Canada
Setting: clinic
Comments: None
Authors name: Karen M. Barlow
Institution: Child Health Research Centre, The University of Queensland
Email: kbarlow@uq.edu.au
Address: Karen M. Barlow, MBChB, Child Health Research Centre, The University of Queensland, Level 6, 62 Graham St, South Brisbane, QLD 4101, Australia.
HC on 15/03/2022 07:05
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Sekundær analyse af Barlow 2020
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Overall
Melatonin
Control
Included criteria: Sleep latency more than 30 minutes, or 2 or more wakes, lasting more than 15 minutes a night, at least 5 nights a week, during more than 1 year.
Excluded criteria: Prior use of Melatonin, liver disease, renal failure, chronic pain, and age less than 2 years
Pretreatment:
Intervention Characteristics
Intervention
Control:
Alvorlige skadevirkninger (SAE) n,N EoT
Ikke alvorlige skadevirkninger (AE) n,N. EoT
Indsovningstid, mean SD EoT
Total sovetid, mean SD, EoT
Antal opvågninger, mean SD, EoT
Sponsorship source: Research grant from Heeren Loo Zorggroep Steunfonds
Country: The Netherlands
Setting: Medication at home
Comments:
Authors name: Wiebe Braam
Institution: Department of Neurology, Geldersee Vallai Hospital
Email: wiebe.braam@sheerenloo.nl
Address: Heeren Loo Zuid-Veluwe, PO Box 75, 6710 BB Ede, The Netherlands
HC on 15/03/2022 06:58
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Uvist om søvnhygiejne er forsøgt
Study design: Randomized controlled cross over study, single center parallel group, two arms.
Study grouping: Crossover
Baseline Characteristics
Overall
Melatonin
Placebo
Included criteria: Those patients with sleep problems occurring more than 3 days per week during the previous 3 months were eligible. Asleep problem was defined as any difficulty withsleep initiation or maintenance that led to impaired quality oflife or interfered with daytime activities for the child or for family members.
Excluded criteria: Exclusion criteria included documented sleep disorders, such as dyssomnias, parasomnias, and circadian rhythm sleep disorders; neuropsychiatric disorders or any other medical condition that might produce sleep problems; or use of medication for insomnia or of antidepressants within 4weeks before the baseline visit.
Pretreatment: None
Intervention Characteristics
Intervention
Control
Søvnkvalitet generelt, mean SD (både subjektive som objektive (Actigraph) estimater
Indsovningstid, mean SD, EoT, (sleep log, Actigraph)
Total sovetid, mean SD, EoT, (sleep log, Actigraph)
Frafald, n,N EoT
Sponsorship source: Not stated
Country: Taiwan
Setting: Single tertiary care hospital in Taiwan
Comments:
Authors name: Yung-Sen Chang
Institution: Department ofMedical Research, NationalTaiwan University Hospital,
Email: gicmbor@ntu.edu.tw
Address: 7 Chung-Shan S Rd, Taipei 100, Taiwan
HKA on 21/03/2022 07:30
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Cross-over RCT på 48 deltagere (1-18 år), med 2 ugers wash-out periode inden cross-over. Undrer mig at kønsfordeling ændrer sig for de to grupper i et cross-over studie!
Study design: Randomized controlled cross-over trial, single center, parallel group, two arms
Study grouping: Crossover
Baseline Characteristics
Overall
Melatonin
Control
Included criteria: Patients were enrolled into the study based on the following criteria: (i) mental retardation with/without epileptic seizures; (ii) age more than 12 months, in order to avoid difficulty with calculating infant dosages; (iii)diagnosis of sleep disorder, defined according to the Diagnostic and Statistical Manual of Mental Disorders(DSM), 4th edition (IV) criteria (307,45) as the circadian rhythm sleep disorder[14]including delayed onset of sleep, multiple night awakenings, and short duration of night sleep through a baseline period of 6 months; (iv) exclusion of medical issues such as gastroesophageal reflux, pain or epileptic seizures mimicking sleep disorders; (v) persisting sleep disturbances despite maintaining appropriate sleep hygiene; (vi) informed consent by parents and/or caregivers. Patients were excluded from the trial if there were: (i) progressive neurological and/or systemic diseases;(ii) age,12 months; (iii) poor compliance from parents/caregivers with the study requirements before trial entry.
Excluded criteria: Patients were excluded from the trial if there were:(i) progressive neurological and/or systemic diseases;(ii) age,12 months; (iii) poor compliance from parents/caregivers with the study requirements before trial entry.
Pretreatment:
Intervention Characteristics
Intervention
Control
Indsovningstid, mean SD EoT (sleep log)
Total sovetid, mean SD, EoT (sleep log)
Antal opvågninger, n,N EoT (sleep log)
Sponsorship source: Not stated
Country: Italy
Setting: Domestic
Comments:
Authors name: Giangennaro Coppola
Institution: Clinic of Child and Adolescent Neuropsychiatry, CIRN, Second University of Naples
Email: n.a.
Address: Via Pansini 5 80131, Naples, Italy
HC on 15/03/2022 07:05
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Obs! aged from 3.6 to 26 years
HKA on 21/03/2022 03:46
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Mener godt denne kan indgå med relevante outcomes
Study design: Randomized controlled trial, single center, two arms
Study grouping: Parallel group
Baseline Characteristics
Overall
Melatonin
Control
Included criteria: Inclusion criteria were having a diagnosis of CF confirmed by sweat test and genetic analysis, the presence of clinical lung disease, the absence of, use of antidepressant or hypnotic medications, clinical stability or the absence of infection or hospitaliza-tion in the last 30 days and signed informed consent from patient or parent.
Excluded criteria: Exclusion criteria were a history of infective exacerbation within the previous 4 wk, hospitalization, co-morbidities, including diabetes mellitus, use of hypnotic-sedative drugs or unwillingness to participate in the study
Pretreatment: None
Intervention Characteristics
Intervention
Control
Søvnkvalitet generelt, mean SD, subjective (Pittsburg sleep quality index) and objective (PSQI) measurements
Indsovningstid, mean SD, EoT, Actigraph
Total sovetid, mean SD, EoT, Actigraph
Antal opvågninger, n,N EoT
Antal opvågninger (WASO), mean SD, EoT, Actigraph
Sponsorship source: Not stated
Country: Brazil
Setting: Domestic
Comments:
Authors name: Claudia de Castro-silva
Institution: Department of Medicine, Universidade Federaldo Ceara ́.
Email: veralice@superig.com.br
Address: Rua Prof. Costa Mendes 1608 - 4Andar, Fortaleza, Ceara ́, Brazil
HC on 15/03/2022 06:10
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Obs! alder 7-28 år, uvist om søvnhygiejniske tiltag har været forsøgt
HKA on 19/03/2022 05:53
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Det er rigtigt at deciderede søvnhygiejniske tiltag ikke nævnes (hvilket iøvrigt oplyses i meget få studier), men der måles på søvnkvalitet og andre søvnparametre inden randomiseringen. Jeg inkluderer i første omgang
Study design: Randomized controlled trial, single center, parallel group
Study grouping: Crossover
Baseline Characteristics
Overall
Melatonin
Placebo
Included criteria: Moderate to severe developmental disability as defined by spastic quadriparesis, mental retardation or global developmental delay with an IQ less than or equal to 50, or autism.
Excluded criteria: n.a.
Pretreatment:
Intervention Characteristics
Intervention
Control
Indsovningstid, mean SD EoT, Sleep log
Total sovetid, mean SD, EoT, Sleep log
Antal opvågninger, n,N, EoT
Antal opvågninger, mean SD, EoT, Sleep log
Sponsorship source: United Cerebral Palsy Association of Greater Indiana
Country: USA
Setting: Clinic
Comments:
Authors name: Nancy N Dodge
Institution: University of Texas, Southwestern Medical Center at Dallas
Email: ndodge@tsrh.org
Address: Welborn Street, Dallas, TX 75219
HC on 15/03/2022 06:16
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Obs! alder 1-12 år
HKA on 19/03/2022 06:17
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Marginalt udenfor vores population, som er 2-24 år!
Study design: Randomized, double blind, placebo-controlled crossover trial
Study grouping: Crossover
Baseline Characteristics
Overall
Melatonin
Placebo
Included criteria: Criteria for participation selection included a motivation to be helped, being unable to go to sleep before 01:00 h at least two out of five nights every school week,and a substantial sense of morning fatigue.
Excluded criteria: Exclusion criteria were prior use of melatonin and use of light therapy
Pretreatment: none - it's a cross over study
Intervention Characteristics
Intervention
Control
Total sovetid, mean SE, EoT (Actigraph (Actiwatch™, Cambridge Neurotechnology, Cambridge, UK))
Døsighed i dagtimer, mean SD, EoT (Karolinska Sleepiness Scale)
Sponsorship source: NATURAL PHARMA International NPI AB, StockholmSweden, was the sponsor of the study, and provided the melatonin and PL capsules.
Country: Sweden
Setting: Domestic
Comments:
Authors name: Berndt Eckerberg
Institution: Stress Research Institute, Stockholm University
Email: arne.lowden@stress.su.se
Address: Stress Research Institute, Stockholm University,106 91 Stockholm, Sweden
HC on 15/03/2022 06:20
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"Diagnose" baseret på et spørgeskema omkring søvn sendt rundt til svenske skolebørn
HKA on 19/03/2022 06:15
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Og det fremgår ikke at der er afprøvet non-farmakologiske tiltag inden melatonin
HKA on 04/04/2022 07:15
Included
Det ser ud som om der rapporteres både indsovningstid og total sovetid, men opgjort i ugedage og weekend.Se tabel 1. Skal lige diskuteres hvilke der skal rapporteres. HUSK det er SE
Study design: Randomized controlled trial, single center, two arms
Study grouping: Parallel group
Baseline Characteristics
Overall
Melatonin group
Placebo group
Included criteria: Age 3 - 12 years. Only those patients were included who were on valproate monotherapy, had a confirmed diagnosis of epilepsy limited to partial or generalized seizures as classified according to the Inter-national Classification of Epileptic Seizures, and were seizure-free at least for the last 6 months
Excluded criteria: All children with a history of psychiatric or other progressive neuro-logical disorder or a chronic hematological, cardiac, hepatic, renal, or thyroid disorder were excluded
Pretreatment: None
Intervention Characteristics
Intervention
Control
Funktionsniveau, mean SD, QOLCE (attention /concentration)
Frafald n,N
Døsighed i dagtimer, mean SD, EoT, Daytime drowsiness score
Livskvalitet hos barnet, mean SD, EoT, QOLCE
Sponsorship source: Not stated
Country: India
Setting: Domestic
Comments:
Authors name: Madhur Gupta
Institution: Department of Pharmacology, Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, New Delhi
Email: madhurgupta@hotmail.com
Address: Shaheed Bhagat Singh Marg, New Delhi 110001, India.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Overall
Melatonin group
Placebo group
Included criteria: Age 3 - 12 years. Only those patients were included who were on valproate monotherapy, had a confirmed diagnosis of epilepsy limited to partial or generalized seizures as classified according to the Inter-national Classification of Epileptic Seizures, and were seizure-free at least for the last 6 months
Excluded criteria: All children with a history of psychiatric or other progressive neuro-logical disorder or a chronic hematological, cardiac, hepatic, renal, or thyroid disorder were excluded
Pretreatment: None
Intervention Characteristics
Intervention
Control
Indsovningstid, mean SD EoT - Actigraph
Total sovetid, mean SD, EoT - Lickert scale
Antal opvågninger (WASO), mean SD, EoT - Actigraph
Sponsorship source: Not stated
Country: India
Setting: Domestic
Comments:
Authors name: Madhur Gupta
Institution: Department of Pharmacology, Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, New Delhi
Email: madhurgupta@hotmail.com
Address: Shaheed Bhagat Singh Marg, New Delhi 110001, India.
Study design: Randomized controlled trial, single center, two arms
Study grouping: Crossover
Baseline Characteristics
Overall
Melatonin group
Placebo group
Included criteria: Six to eleven years old pre-pubertal (Tanner stage I) children with epilepsy, with normal development based on school placement (in appropriate grade based on age) and developmental history or IQ>70, were screened with sleep behavior questionnaire (SBQ).2 A combined score of 30, or more on sleep fragmentation, parasomnia and daytime drowsiness subscales was required for enrollment. We enrolled pre-pubertal children to avoid patients with potential delayed sleep phase syndrome where melatonin may have a phase advancing effec
Excluded criteria: Subjects were excluded if they had a history of loud snoring, diagnosis of obstructive sleep apnea [obstructive apnea hypopnea index >2/hour] or periodic limb movement (PLM) disorder [PLM Index >5/ hour] on polysomnography. We also excluded patients with Vagus nerve stimulator, history of a major psychiatric disease, pervasive development disorder, severe neuro-developmental disabilities, immune disorders or lympho-proliferative disorders. Concurrent use of hypnotics, stimulants, systemic corticosteroids or other immuno-suppressants, or history of using SR melatonin was also exclusionary
Pretreatment: None - it's a cross over study
Intervention Characteristics
Intervention
Control
Søvnkvalitet generelt, mean SD - subjective measurements (Sleep Behavior Questionnaire (SBQ))
Frafald n,N
Indsovningstid, mean SD, EoT - Sleep log
Total sovetid, mean SD, EoT - Lickert scale
Antal opvågninger (WASO), n,N, EoT - Actigraph
Sponsorship source: Sejal V Jain is funded by CTSA and CReFF,Katherine Holland is funded by NIH grants R01 NS062756, R01 NS062806, and R01 NS065020.Narong Simakajornboon is funded by NIH U01DK072493,Dean Beebe is funded by NIH grants R01 HL092149, R01 NR012734, and UL1 RR026314, American Diabetes Association grant ADA 7-13-CE-32 and Lupus Foundation of America grant 013-02.Anna Byars is funded by NIH grants 1R01-NS082320-01, 1P20-NS080199-01, and 1R01-NS065840 and contract HHSN275200900018C and TS Alliance/Simonds Foundation/NovartisTracy Glauser is funded by NIH grants 2U01-NS045911, U10-NS077311, R01-NS053998, R01-NS062756, R01-NS043209, R01-LM011124, and R01-NS065840.
Country: USA
Setting: Domestic
Comments:
Authors name: Sejal V Jain
Institution: Division of Neurology, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH
Email: Sejal.Jain@cchmc.org
Address: Cincinnati Children’s Hospital Medical Center, 3333 Burnet Ave, MLC 2015, Cincinnati, OH 45229,
HKA on 18/03/2022 22:50
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Lille cross-over studie (11 deltagere, hvoraf 1 drop-out)
Study design: Randomized controlled trial, single center, parallel group
Study grouping: Crossover
Baseline Characteristics
Overall
Melatonin group
Placebo group
Included criteria: 9 females with Rett syndrome
Excluded criteria: Not stated
Pretreatment: None - it's a crossover study
Intervention Characteristics
Intervention
Control
Indsovningstid, mean SD, EoT - Actigraph
Total sovetid, mean SD, EoT - Actigraph
Sleep efficiency, mean SD, EoT
Antal opvågninger, n,N, EoT
Sponsorship source: Not stated
Country: USA
Setting: clinic
Comments:
Authors name: Angela McArthur
Institution: Oregon Health Sciences University
Email: Not stated
Address: 3181 SW Sam Jackson Park Rd, Portland, OR97201-3098
HKA on 19/03/2022 03:13
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Kun 9 deltagere, alle piger
Study design: Randomized controlled trial, single center, parallel group
Study grouping: Crossover
Baseline Characteristics
Overall
Melatonin group
Placebo group
Included criteria: Patients were selected if they, or their family, reported disturbed sleep of any kind
Excluded criteria: Patients were excluded if they had taken melatonin in the past 4 weeks, had a diagnosis of obstructive sleep apnea, had known hypersensitivity to melatonin, had a musculoskeletal abnormality that prevented them from being able to wear the actigraphy wristband, or were pregnant
Pretreatment: None - it's a cross-over study
Intervention Characteristics
Intervention
Control
Søvnkvalitet generelt, mean SD, - subjective measurements (Sleep disturbances Scale in children (SDSC))
Antal opvågninger, n,N, EoT
Total sovetid, mean SD, EoT - Actigraph
Livskvalitet hos barnet, mean SD, EoT - (QOLCE-55)
Sponsorship source: National Health and Medical Research Council (NHMRC) Program Grants (628952, 1091593)
Country: Australia
Setting: Clinic
Comments:
Authors name: Kenneth Myers
Institution: Montreal Children’s Hospital
Email: kenneth.myers@mcgill.ca
Address: 1001 Décarie Blvd, Montreal, PQ, H4A 3J1, Canada
HC on 15/03/2022 07:24
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aged 2 to 50 years
HKA on 21/03/2022 04:15
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Der er kun én deltager over 24 år? Den kunne godt være relevant og er fra 2018. Cross over RCT, men med blot 13 deltagere med Dravets syndrome (epilepsi)
Study design: Randomized controlled trial, single center, four arms
Study grouping: Parallel group
Baseline Characteristics
Overall:
Melatonin group:
Control (placebo) group:
Furthermore, two intervention arms: Bright light (n=10), and combination of Bright light, and melatonin (n=10) – not relevant for this review.
Included criteria: (1) living in Bergen, Norway, (2) age 16–25 years, (3) good general health as specified by the exclusion criteria and (4) DSPD diagnosis
Excluded criteria: Sleep disorders other than DSPD based on subjective reports and polysomnography (apnea-hypopnea index 45 and periodic limb movement index 415), moderate to severe psychopathology or treatment for psychopathology within the last four weeks (based on SCID-I interview (First et al., 1995)), somatic disorders or conditions assumed to affect sleep (i.e. migraine, B12 deficiency), all serious somatic disorders (i.e. rheumatoid arthritis and diabetes), medications assumed to affect sleep (i.e. sedative anti-histamines, antidepressants and hypnotics), substance abuse or night work, IQ570 (Raven’s matrices (Raven, 2000; Raven et al., 2000)), breast feeding and pregnancy.
Pretreatment: The participants kept a sleep diary and wore an actigraph for seven days prior to intervention (baseline assessment)
Intervention Characteristics
Intervention
Control
Søvnkvalitet generelt, mean SD, EoT
Subjective measurement: Pittsburg sleep quality index (PSQI)
Objective measurement: Actigraph (Actiwatch™ recorder AW7, Cambridge Neurotechnology, Cambridge, UK)
Indsovningstid, mean SD, EoT
Total sovetid, mean SD, EoT
Antal opvågninger, n,N EoT
Sponsorship source: Meltzer Foundation for grant funding used for the execution of the study
Country: Norway
Setting: Domestic
Comments:
Authors name: Ingvild West Saxvig
Institution: Department of Public Health and Primary Care, University of Bergen, Postboks 7804, 5020 Bergen, Norway. Tel: +47 55586064. Fax: +47 55586130. E-mail: ingvild.saxvig@isf.uib.no
Email: ingvild.saxvig@isf.uib.no
Address: Postboks 7804, 5020 Bergen, Norway. Tel: +47 55586064. Fax: +47 55586130. E-mail: ingvild.saxvig@isf.uib.no
HC on 15/03/2022 06:50
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Obs! age 16–25 years, uvist omkring søvnhygiejne
HKA on 19/03/2022 06:01
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population OK, forsøget med melatonin varer kun 2 uger og rigtigt at der ikke er oplyst om forudgående initiativer. Revurder.
Study design: Randomized controlled trial, single center parallel group, two arms
Study grouping: Parallel group
Baseline Characteristics
Overall:
Intervention:
Control:
Included criteria: Children suffering from sleep onset insomnia more than 4 nights a week during past 12 months, aged 6-12.
Excluded criteria: n.a.
Pretreatment: n.a.
Intervention Characteristics
Intervention
Frafald n,N
Indsovningstid, mean SD EoT - Actigraph (Gähwiler Electronics, Hombrechtikon, Switzerland))
Total sovetid, mean SD, EoT - Actigraph
Sponsorship source: Jan Dekker en dr Ludgardine Bouwman Foundation and Dutch Society for sleep-wake Research
Country: The Netherlands
Setting: Domestic
Comments:
Authors name: Marcel Smits
Institution: Hospital De Gelderse Vallai, sleep Centre
Email: Smits.M@inter.nl.net
Address: Stationsweg 86, 6711 PV Ede, The Netherlands
HKA on 21/03/2022 06:01
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40 deltagere placebo contr RCT - alder 6-12 år og relevante outcomes
Study design: Randomized controlled trial, single center parallel group, two arms
Study grouping: Parallel group
Baseline Characteristics
Overall:
Intervention:
Control:
Included criteria: Children suffering from sleep onset insomnia more than 4 nights a week during past 12 months, aged 6-12.
Excluded criteria: n.a.
Pretreatment: n.a.
Intervention Characteristics
Intervention
Control
Funktionsniveau, mean SD, EoT - FS-II tool
Frafald n,N
Indsovningstid, mean SD EoT - Actigraph (Gähwiler Electronics, Hombrechtikon, Switzerland))
Total sovetid, mean SD, EoT - Actigraph
Sponsorship source: Jan Dekker en dr. Lugardine Bouwman Foundation
Country: The Netherlands
Setting: Domestic
Comments:
Authors name: Marcel Smits
Institution: Hospital Gelderse Vallei, Sleep centre
Email: smitsm@zgv.nl
Address: Willy Brandtlaan 10, Box 9025, 6710HN Ede, The Netherlands
HKA on 21/03/2022 07:26
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Population OK og med brugbare data
Study design: RCT, single center, parallel group, two arms.
Study grouping: Parallel
Baseline Characteristics
Overall:
Intervention:
Control:
Included criteria: not stated
Excluded criteria: not stated
Pretreatment: not stated
Intervention Characteristics
Intervention
Control
Søvnkvalitet generelt, mean SD - Subjective measurements (Childrens sleep habits questionnaire)
Frafald n,N
Indsovningstid, mean SD, EoT - Actigraph
Total sovetid, mean SD, EoT - Actigraph
Døsighed i dagtimer, mean SD, EoT - Daytime drowsiness score
Sponsorship source: Kashan University of Medical Sciences, Grant/Award Number: 96110
Country: Iran
Setting: Domestic
Comments:
Authors name: Abbas Taghavi Ardakani
Institution: Infectious Diseases Research Center, Kashan University of Medical Sciences, Kashan, Iran
Email: asemi_r@yahoo.com
Address: n.a.
HKA on 21/03/2022 07:33
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Brugbare data for en population (70 deltagere), alder 6-12 år, med atopisk dermatitis.
Study design: Randomised controlled trial, single center, parallel group
Study grouping: Parallel group
Baseline Characteristics
Overall:
Melatonin group:
Control (placebo) group:
Included criteria: As for studies by Smits et al. 2001 and 2003
Excluded criteria: Exclusion criteria were sleep maintenance insomnia (one awakening >30 min or two or more awakenings of >5 min summing up to at least 40 min, occurring on one or more nights a week, for a period of at least 4 weeks preceding the start of the trial); disturbed sleep architecture measured by ambulatory polysomnography; mental handicap; severe learning disabilities; any prior use of melatonin; liver diseases; renal failure; use of hypnotics, antidepressants, and neuroleptics; chronic pain; and severe neurologic or psychiatric disorders.
Pretreatment:
Intervention Characteristics
Intervention
Control
Individual patient data of two previously published randomised, placebo-controlled, double blind, clinical trials, using similar methodology (Smits et al., 2001, 2003), were combined.
Aim of this study is whether melatonin efficacy can be predicted from the time at which administration occurs within the circadian rhythm.
Sponsorship source: Supported by the Dr. Ludgardine Bouwman Foundation
Country: the Netherlands
Setting: Domestic
Comments:
Authors name: Kristiaan B. van der Heijden
Institution: Department of Child and Adolescent Psychiatry, University of Amsterdam,
Email: k.b.vanderheijden@amc.uva.nl
Address: Meibergdreef 9, PO Box 12474, Amsterdam
HKA on 18/03/2022 22:37
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Predictive - ikke umiddelbart relevant, trods comparator er placebo
Study design: Randomized controlled trial, single center, four arms
Study grouping: Parallel group
Baseline Characteristics
Overall:
Melatonin group:
Control (placebo) group:
Included criteria: Children were eligible if they were 6–12 years old, suffering from sleep onset insomnia more than four nights a week for more than 1 year, and insufficiently responded to sleep hygiene improving measures based on parental reports. Sleep onset insomnia was defined as sleep onset later than 8:30 p.m. in children aged 6 years and for older children 15 min later per year until age 12 (10:00 p.m.).Furthermore, the latency between lights-off time and sleep onset (sleep onset latency) had to be more than 30 min on average. Their sleep onset had not been advanced sufficiently with the usual sleep hygiene improving measures. Further inclusion criteria were normal sleep architecture as indicated by a normal hypnogram, performed within 2 months prior to participation, and written informed consent obtained from parents
Excluded criteria: Exclusion criteria were chronic sleep onset insomnia due to psychiatric or pedagogic problems, known intellectual disability, pervasive develop-mental disorder, chronic pain, known disturbed hepatic or renal function, epilepsy, prior use of melatonin, and use of stimulants, neuroleptics, benzodiazepines, clonidine, anti depressants, hypnotics, or beta-blockers within 4 weeks before enrollment.
Pretreatment: None
Intervention Characteristics
Intervention 1
Intervention 2
Intervention 3
Control
Indsovningstid, mean SD EoT
Total sovetid, mean SD, EoT
Antal opvågninger, n,N EoT
Sponsorship source: Not stated
Country: The Netherlands
Setting: Domestic
Comments:
Authors name: Ingeborg M. van Geijlswijk
Institution: Department of Pharmacy, Faculty of Veterinary Medicine, Utrecht Universit
Email: i.m.vangeijlswijk@uu.nl
Address: Yalelaan 106, 3584 CM Utrecht, The Netherlands
HKA on 18/03/2022 22:46
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Dosis afhængige gavnlige effekter på børn 6-12 år, der har haft søvnproblemer i mere end et år
HKA on 05/04/2022 00:37
Included
De opgiver indsovningstid som Mean diff sammenlignet med placebo gruppen, men det er lidt svært at tolke værdierne for SOL (sleep onset latency), da værdier for alle tre anvendte melatonin-doser er positive, dvs længere tid end placebo-gruppen, hvilket ikke kan være tilfældet.
Study design: Follow up from the RCT study Van Geijlswijk, 2010
Study grouping: Single arm
Baseline Characteristics
Overall:
Included criteria: Not stated
Excluded criteria: Not stated
Pretreatment:
Intervention Characteristics
Intervention 1
Sleep quality, mean SD - CSQH
Effects of prolonged use of melatonin, EoT
Dropouts, n,N EoT
Sponsorship source: Not stated
Country: The Netherlands
Setting: Domestic
Comments:
Authors name: Ingeborg M. van Geijlswijk
Institution: Department of Pharmacy, Faculty of Veterinary Medicine, Utrecht Universit
Email: i.m.vangeijlswijk@uu.nl
Address: Yalelaan 106, 3584 CM Utrecht, The Netherlands
HC on 15/03/2022 18:39
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FU studie af van Geijlswijk et al. 2010, med langtidsbivirkninger
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Overall:
Intervention:
Control (placebo) group:
Included criteria: (1) age between 7 and 12 years old; (2) chronic sleep onset problems, as indicated by (a) complaints of inability to fall asleep at the desired clock time (sleep onset later than 20:45 h in children aged 7 years and for older children 15 minutes later per year) and a latency between lights-off time and sleep onset (sleep onset latency) of more than 30 minutes, and (b) the symptoms were present for at least four nights a week, for at least 1 month during a regular school period; (c) the sleep problems resulted in problems with daytime functioning.
Excluded criteria: (1) a diagnosis of a childhood psychiatric disorder other than ADHD or autism spectrum disorder; (2) chronic pain; (3) known disturbed hepatic or renal function; (4) Roter or Dubin-Johnson syndrome; (5) epilepsy; (6) use of neuroleptics, benzodiazepines, clonidine, antidepressants, hypnotics, or β-blockers within 4 weeks before enrolment; (7) intellectual disability. Furthermore, other psychiatric disorders than ADHD or autism, for example, bipolar disorders, because these are often associated with a broader range of sleep problems.
Pretreatment:
Intervention Characteristics
Intervention 1
Control
Søvnkvalitet generelt, mean SD, EoT- Sleep efficacy (%) / AW4 actiwatches (Cambridge Neurotechnology Ltd, Cambridge,UK) - Actigraph
Indsovningstid, mean SD, EoT
Total sovetid, mean SD, EoT
Antal opvågninger, n,N EoT
Sponsorship source: Pharma Nord sponsored the melatonin and placebo tablets for the study
Country: The Netherlands
Setting: Domestic
Comments:
Authors name: Annette van Maanen
Institution: Research Institute of Child Development and Education, University of Amsterdam.
Email: A.vanMaanen@uva.nl
Address: PO Box 15776, 1001 NG Amsterdam, The Netherlands
Study design: Randomized controlled trial, parallel
Study grouping: Cross-over
Baseline Characteristics
Overall:
Melatonin group:
Control (placebo) group:
Included criteria: Participants were eligible to participate if they were between the ages of 2 and 18 yr, had multiple NDD and chronic DSPS or ISM (longer than 1.5 yr)
Excluded criteria: Children were not eligible when their sleep difficulties were mild and not associated with daytime symptoms of insomnia (such as excessive drowsiness, inability to stay awake, lethargy, increased irritability and decreased functioning) and had progressive degenerative neurologic disorders, or life-threatening illnesses
Pretreatment: None, it's a crossover trial
Intervention Characteristics
Intervention
Control
Søvnkvalitet generelt, mean SD - Objective measurements - Actigraph
Funktionsniveau, mean SD - CGI (Parents global assessment scale)
Frafald n,N
Indsovningstid, mean SD EoT - Actigraph
Total sovetid, mean SD, EoT - Actigraph
Antal opvågninger, n,N, EoT
Sponsorship source: This study was sponsored as an investigator-initiated trial by Circa Dia BV
Country: Canada
Setting: Clinic
Comments:
Authors name: Michael B. Wasdell
Institution: Diagnostic Neurophysiology, BC Childrens Hospital
Email: jjan@cw.bc.ca
Address: 4500 Oak Street, Vancouver, BC, Canada V6H 3N1
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Overall
Intervention
Control
Included criteria: Inclusion criteria were 1) living in Bergen, Norway; 2) aged 16 to 25 years; 3) good general health as speci-fied by the exclusion criteria (see below); and 4) ful-filling the diagnostic criteria for DSPD. The participants were diagnosed according to the criteria found in the International Classification of Sleep Disorders, 2nd version (ICSD-2) (American Academy of Sleep Medicine, 2005), operationalized for this study as the following: 1) problems falling asleep in the evening, 2) falling asleep after 0200 h at least 3 days a week, 3) ability to sleep until early afternoon, 4) problems waking up in time for school/work, 5) early wake-up times associated with extreme day-time sleepiness, 6) good subjective sleep quality and duration when given the opportunity to sleep at self-chosen times, and 7) verbally self-reporting the afore-mentioned sleep problems as chronic (>6 months).The DSPD diagnosis was confirmed as required by the ICSD-2 criteria by sleep diary data covering a 1-week period and showing a delayed sleep pattern
Excluded criteria: Exclusion criteria were sleep disorders other than DSPD, moderate to severe psychopathology (see later for procedure), conditions assumed to affect sleep (i.e., migraine, B12 deficiency), all serious somatic disorders (i.e., rheumatoid arthritis, diabe-tes), medications or treatments assumed to affect sleep (i.e., sedative antihistamines, antidepressants, hypnotics), substance abuse, night work, intelligence quotient <70, breast feeding, and pregnancy.
Pretreatment: None
Intervention Characteristics
Intervention 1
Control
Funktionsniveau, mean SD
Frafald n,N
Døsighed i dagtimer, mean SD, EoT - Karolinska Sleepiness Scale, Epworth Sleepiness Scale, Fatigue Questionnaire
Sponsorship source: Meltzer Foundation for grant funding used for the execution of this study
Country: Norway
Setting: Domestic
Comments:
Authors name: Ane Wilhelmsen-Langeland
Institution: Department of Global Health and Primary Care, University of Bergen, Bergen, Norway, †Norwegian Competence Center for Sleep Disorders, Haukeland University Hospital, Bergen, Norway, ‡Department of Psychosocial Science, University of Bergen, Bergen, Norway,
Email: wilhelmsen-langeland@ipr.no
Address: University of Bergen, Postboks 7804, 5020 Bergen, Norway
HC on 15/03/2022 06:25
Select
Obs! aged 16 to 25 years. Uvist om søvnhygiejne tiltag er blevet afprøvet
HKA on 04/04/2022 23:25
Included
Vi kigger kun på den første periode
No new studies
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Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Quote: "participants were randomly assigned by using a random-block-size design (block sizes 3, 6, and 9) to 3 parallel treatment groups"
Judgement Comment: Nothing mentioned
Quote: "Randomization was performed with a computer-generated sequence by special- ized personnel who had no further involvement in the rest of the trial."
Quote: "Each patient enrolled into the study was randomized to oral synthetic fast-release melatonin or placebo, and then entered phase 1 (melatonin or placebo) that lasted 4 weeks."
Judgement Comment: Nothing mentioned regarding method
Quote: "Patients were then randomized into the melatonin or placebo group."
Judgement Comment: No information on method provided
Judgement Comment: Randomization performed by pharmacy personal
Quote: "The cap- sules were dispensed in numbered sets of three bottles, labelled 1, 2 and 3, each containing six capsules. The sets had been randomized and were delivered together with sealed data in envelopes, separate for each set."
Quote: "A randomization code list was prepared by a statistician who was not connected to the study. The permutation of code numbers was computer generated for the treatment groups."
Quote: "randomization code list was prepared by a statistician, who was not connected to the study. The permutation of code numbers was computer generated for the treatment groups."
Quote: "The Investigational Pharmacy at CCHMC performed the randomization by random number generators in www.randomization.com,"
Judgement Comment: Not stated
Quote: "Randomization was performed by a pharmacist at the Austin Health Clinical Trials Pharmacy. After"
Quote: "Two randomization lists were produced (four groups  two-week intervention, two groups  three-month follow-up), using the Internet–based program Research Randomizer (www.randomizer.org/form.htm)."
Judgement Comment: No information on method
Judgement Comment: Method not mentioned
Quote: "Randomization assignment was conducted using computer- generated random numbers."
Judgement Comment: Method not mentioned
Quote: "For this trial, a specialized internet software application (Medsys/De Nieuwe Coster/2004) was developed for randomization of participants, for calculation of the assigned dose (based on body weight), and for collection of sleep log data."
Quote: "For this trial, a specialized internet software application (Medsys/De Nieuwe Coster/2004) was developed for randomization of participants, for calculation of the assigned dose (based on body weight), and for collection of sleep log data."
Quote: "Randomization took place using a preset list specifying whether a participant should receive medication (melatonin or placebo) or light on a 2:1 ratio."
Quote: "Children who were randomized to medication received either melatonin or placebo, dependent on a coding deter- mined by the manufacturer, blind for the researcher and treatment provider (neurologist). Only"
Quote: "A blocked randomization method was employed in which every four patients had equal probability of receiving either of the two treatment sequences."
Quote: "Patients were randomly assigned by the hospital pharmacy to receive either melatonin or placebo first."
Quote: "The randomization lists were created (4 groups for the 2-week intervention and 2 groups for the 3-month follow-up) using the Internet-based program Research Randomizer"
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
The computergenerated randomization list was created and held by an external statistician
Judgement Comment: Nothing mentioned
Quote: "Allocation codes were disclosed only after the entire clinical trial was completed."
Quote: "The melatonin and placebo tablets were identical in appearance."
Judgement Comment: Nothing mentioned
Quote: "Melatonin and placebo were supplied in identical 3-mg capsules"
Judgement Comment: Identical filler and capsules
Quote: "The melato- nin and PL were administered to the students as hard- gelatin capsules, which were indistinguishable from one another by appearance, taste and smell. The cap- sules were dispensed in numbered sets of three bottles, labelled 1, 2 and 3, each containing six capsules. The sets had been randomized and were delivered together with sealed data in envelopes, separate for each set. In"
Quote: "The placebo tablets, identical in shape, size, color, and packaging, were"
Quote: "Ltd, Mumbai, India) were used. <b>The placebo tablets, identical in shape, size, color, and packag- ing, were specially prepared for the study by Aristo Pharmaceuticals Ltd. They</b> contained dicalcium phosphate in place"
Quote: "random number generators in www.randomization.com, <b>ensured blinding via over- encapsulation of both the melatonin and placebo pills to have the same appearance, and dispensed the study medications. The</b> pharmacy and the statistician were"
Judgement Comment: Identical looking capsules
Judgement Comment: Nothing mentioned
Quote: "Melatonin and placebo capsules were packed in iden- tical containers,"
Judgement Comment: Melatonin and placebo provided in identical packages. Code was broken when all data was recorded
Judgement Comment: All investigators were unaware of treatment allocation. Code broken when all data were recorded
Quote: "Randomization and alloca- tion concealment for both the researchers and participants were carried out by a trained staff at the pediatric clinic."
Judgement Comment: No apparent sources of bias
Quote: "The capsules were packed in unit dose strips, labeled with “Melatonine×mg” masked with an X to keep participants blind to the treatment allocation and subject number."
Quote: "The capsules were packed in unit dose strips, labeled with “Melatonine×mg” masked with an X to keep participants blind to the treatment allocation and subject number."
Quote: "Children who were randomized to medication received either melatonin or placebo, dependent on a coding deter- mined by the manufacturer, blind for the researcher and treatment provider (neurologist). Only at post-treatment,"
Quote: "placebo was prepared by the hospital pharmacy in identical capsules"
Quote: "Participants were further informed that the capsules contained either melato- nin or maize starch. The melatonin and placebo capsules were packed in identical containers differ- entiated by a number code (1 and 2). In"
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Quote: "All investigators, outcome assessors, parents, and children were blinded to treatment groups"
Judgement Comment: Open label for participants + personnel
Quote: "The participants and their caregivers, treating phy- sicians, those assessing outcomes, and those analyzing the data were all masked to group assignment."
Judgement Comment: Participants blinded - no info on personel
Quote: "a previously described method [26]. <b>Patients and investigators were unaware of treatment allocation at all times.</b> Clinical and laboratory investigations The"
Judgement Comment: Personal not blindedParticipants blinded
Quote: "The randomization of the first two bottles was blind to students and study team and the code was broken only after all study procedures were terminated."
Judgement Comment: Not mentioned who is blinded
Judgement Comment: Not mentioned who is blinded
Quote: "and dispensed the study medications. <b>The pharmacy and the statistician were unblinded while the rest of the study team was blinded to the allocation throughout data collection, entry and cleaning.</b> 2.8 Statistical methods All outcome"
Judgement Comment: Nothing mentioned
Judgement Comment: Seems that participants and investigators were blinded during entire study
Quote: "The two-week intervention was double blinded."
Judgement Comment: Unclear who was blinded
Judgement Comment: Nothing mentioned
Judgement Comment: see above
Quote: "Randomization assignment was conducted using computer- generated random numbers. Randomization and alloca- tion concealment for both the researchers and participants were carried out by a trained staff at the pediatric clinic. Compliance"
Judgement Comment: All investigators were unaware of treatment allocation. Code broken when all data were recorded
Quote: "All participants, care providers, and investigators involved in the study were unaware of the treatment allocation."
Quote: "All participants, care providers, and investigators involved in the study were unaware of the treatment allocation."
Quote: "Pharma Nord) at 19:00 h. <b>Children in the melatonin condition received melatonin for 3 to 4 weeks. In the placebo condition, children received placebo tablets, which looked iden- tical to the melatonin tablets.</b> Sleep diary reports indicated that"
Quote: "Children who were randomized to medication received either melatonin or placebo, dependent on a coding deter- mined by the manufacturer, blind for the researcher and treatment provider (neurologist). Only at post-treatment, when they returned to the center, the code was broken by the neurologist."
Quote: "Patients, caregivers, study inves- tigator, and clinical staff were blind to the medication randomization."
Quote: "Patients, caregivers, study inves- tigator, and clinical staff were blind to the medication randomization."
Quote: "The 2-week treatment study was double blinded."
Judgement Comment: Unclear who was blinded
Detection bias due to knowledge of the allocated interventions by outcome assessors
Quote: "All investigators, outcome assessors, parents, and children were blinded to treatment groups"
Judgement Comment: All investigators blinded
Quote: "The participants and their caregivers, treating phy- sicians, those assessing outcomes, and those analyzing the data were all masked to group assignment. Allocation codes"
Judgement Comment: Nothing mentioned
Judgement Comment: Patients and investigators were unaware of treatment allocation at all times.</b> Clinical and laboratory investigations The
Judgement Comment: Families blinded. Based on sleep logs
Quote: "The randomization of the first two bottles was blind to students and study team and the code was broken only after all study procedures were terminated. The"
Judgement Comment: Not mentioned who is blinded
Judgement Comment: Not mentioned who is blinded
Quote: "and dispensed the study medications. <b>The pharmacy and the statistician were unblinded while the rest of the study team was blinded to the allocation throughout data collection, entry and cleaning. 2.8 Statistical</b> methods All outcome measures and"
Judgement Comment: Nothing mentioned
Quote: "After all patients had com- pleted the study, initial unblinding was partial, so that in- vestigators learned whether individual patients had received “Treatment A” first or second but did not know if “Treatment A” was melatonin or placebo. This allowed statistical analysis to be performed while investigators were still blinded to treat- ment received. After"
Judgement Comment: Unclear who was blinded
Judgement Comment: All investigators were blinded
Judgement Comment: Same as allocation concealment
Quote: "Randomization and allocation concealment for both the researchers and participants were carried out by a trained staff at the pediatric clinic. Compliance rate"
All investigators were unaware of treatment allocation. Code broken when all data were recorded
Quote: "treatment allocation and subject number. <b>All participants, care providers, and investigators involved in the study were unaware of the treatment allocation. Data analysis</b> The time measurements bed-, sleep"
Quote: "treatment allocation and subject number. <b>All participants, care providers, and investigators involved in the study were unaware of the treatment allocation. Data analysis</b> The time measurements bed-, sleep"
Quote: "blind for the researcher and treatment provider (neurologist). Only at post-treatment, when"
Judgement Comment: Only objective measures (actigraph)
Quote: "Patients, caregivers, study inves- tigator, and clinical staff were blind to the medication randomization. Unblinding of"
Judgement Comment: Unclear who was blinded
Attrition bias due to amount, nature or handling of incomplete outcome data
Judgement Comment: No apparent sources of bias - Protocol available: http://www.clinicaltrials.gov/; NCT01874847
Judgement Comment: No apparent sources of bias
Judgement Comment: Lidt uklart hvilken impact hhv 4 (melatonin gruppen) og 6 (placebo gruppen) har i dette cross over study, idet alle deltagere EoT har modtaget intervention og placebo. 79% gennemfører hele studiet
Quote: "Seven patients (28%) were lost to the study because of the following reasons: change of mind about participation in two; intercurrent illness in other two; family lost to follow- up due to poor results in three patients while assuming first phase placebo."
Judgement Comment: No mentioned on how many dropped out pr group
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent source of bias
Quote: No protocol identified
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias - Protocol available: http://www.clinicaltrials.gov/;NCT00965575
Judgement Comment: No dropouts
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias Dropouts from dim light melatonin intervention group (n=1) and placebo group (n=1). Some missing data. ITT analysis. Likely no influence on outcome.
Judgement Comment: No apparent sources of bias. No protocol identified
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
No protocol identified
Judgement Comment: Afhængig af outcome er der en samlet dropout rate på 5-10 deltagere
Judgement Comment: Afhængig af outcome er der en samlet dropout rate på 5-10 deltagere
Quote: "Data were analyzed on an intention to treat basis."
Judgement Comment: NI about missing data
Judgement Comment: One patient (1%) withdrew and was hence excluded from the analysis.
Judgement Comment: No apparent sources of bias
Reporting bias due to selective outcome reporting
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias (protocol avilable http://www.clinicaltrials.gov/; NCT01638234)
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Quote: "Clinical Trials Notification Scheme (protocol number 2241)" Protocol available: http://www.clinicaltrials.gov/;NCT00965575
Quote: "(ClinicalTrials.gov NCT00834886)."
Judgement Comment: Protocolled 2nd primary outcome:Subjective sleepiness; Karolinska sleepiness scale (KSS). The KSS is a scale in which the subjects rate their concurrent sleepiness level. The scale is verbally anchored with steps ranging from 1 ("very alert") to 9 ("very sleepy, fighting sleep, effort to stay awake").This self-reported outcome is not reported.No statement regarding deviations from protocol. BSI and PSQI and DLMO not pre-specified either.
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Quote: "IRCT2017082733941N12). The"
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias. Randomized Controlled Trial Number Register (ISRCTN20033346).
Judgement Comment: No apparent sources of bias. Randomized Controlled Trial Number Register (ISRCTN20033346).
Quote: "Nederlands Trial Register (NTR): NTR4045"
Judgement Comment: https://www.trialregister.nl/trial/3884 This study seems free from selective outcome reporting No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Bias due to problems not covered elsewhere in the table
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No other sources of bias detected
Judgement Comment: No apparent sources of bias
Judgement comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Quote: "The authors wish to thank Ruth Milner, Derryck Smith, the Department of Psychiatry, Diane Fast, Hilary Espezel, and Circa Dia BV for their support."
Quote: "This study was sponsored as an investigator-initiated trial by Circa Dia BV. Dr. Jan holds a research contract/grant with Circa Dia BV. Professor Rietveld is the Scientific Director of Circa Dia BV. Dr. Weiss is a consultant, an advisory board and speakerÕs bureau member, and holds research contracts/grants with Eli Lilly, Shire, and Janssen Ortho; she is a consultant to and an advisory board and a speakerÕs bureau member of Novartis; she holds a research contract with and is a consultant to Purdue; she is a consultant to and an advisory board member of Johnson & Johnson; and holds a research contract/grant with Circa Dia BV."
Judgement Comment: Circa Dia BV (medical provider) initiated the trial and authors hold positions within the company. No descriptions of the sponsor's role(s).
Judgement Comment: No apparent sources of bias