Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-02-28 @ 5:31 AM
Study NCT ID:
NCT01993251
Status:
COMPLETED
Last Update Posted:
2025-10-02
First Post:
2013-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Melatonin Restore Sleep Architecture in Autistic Children
Sponsor:
Hospices Civils de Lyon
Organization:
Study Overview
Official Title:
Does Melatonin Restore Sleep Architecture in Autistic Children?
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOMELIA
Brief Summary:
Although behavioral disorders origins in autistic children are still unclear, they seem to be influenced by sleep disorders. Results of studies performed on sleep quality in autistic children showed a high prevalence of sleep disorders in these children, estimated between 50 and 80% compared to children with typical development and insomnia is one of the sleep disorders most frequently reported by autistic children's parents. Others studies showed circadian rhythm disorder in autistic children which could be the consequence of genetic abnormalities in the melatonin synthesis and the melatonin role in the synaptic transmission modulation.
Melatonin by its sedative effects and its action on circadian pacemaker is a promoter of sleep proposed for insomnia treatment and circadian rhythm disorders.
Two major recent studies (not yet published) in the United States and in England seek to show the effectiveness of melatonin by testing the effects of three doses of melatonin on reducing sleep disorders.
It is therefore interesting and important to conduct a parallel study to assess the melatonin effect not only on the reduction of sleep disorders (sleep onset latency, total sleep time…), but on sleep quality (number of nocturnal awakenings).
The strength of this study lies in the combination of several measurement tools to assess the melatonin dose-effect on all parameters in both physiological (actimetrics, polysomnography), biological (dosage 24h sulfatoxymelatonin), behavioral (sleep questionnaire, index of insomnia severity, rating scale autistic disorder) as well as possible side effects.
The primary objective is to determine the most effective dose of melatonin to improve sleep quality in autistic children.
Melatonin by its sedative effects and its action on circadian pacemaker is a promoter of sleep proposed for insomnia treatment and circadian rhythm disorders.
Two major recent studies (not yet published) in the United States and in England seek to show the effectiveness of melatonin by testing the effects of three doses of melatonin on reducing sleep disorders.
It is therefore interesting and important to conduct a parallel study to assess the melatonin effect not only on the reduction of sleep disorders (sleep onset latency, total sleep time…), but on sleep quality (number of nocturnal awakenings).
The strength of this study lies in the combination of several measurement tools to assess the melatonin dose-effect on all parameters in both physiological (actimetrics, polysomnography), biological (dosage 24h sulfatoxymelatonin), behavioral (sleep questionnaire, index of insomnia severity, rating scale autistic disorder) as well as possible side effects.
The primary objective is to determine the most effective dose of melatonin to improve sleep quality in autistic children.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013-001230-17 | EUDRACT_NUMBER | None | View |