Sleep Disorders Clinical Trial
Official title:
Does Melatonin Restore Sleep Architecture in Autistic Children?
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02188498 -
Electrocardiography Data Analysis in Sleep Disorders
|
||
| Completed |
NCT00990106 -
Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD)
|
N/A | |
| Completed |
NCT00942253 -
Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS)
|
Phase 2 | |
| Completed |
NCT00163670 -
The Impact of Sleep Disorders on Motor Vehicle Accidents
|
N/A | |
| Completed |
NCT00203827 -
Pediatric Sleep Questionnaire: Use for Collection of Clinical Data
|
N/A | |
| Completed |
NCT00256685 -
Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause
|
Phase 3 | |
| Completed |
NCT00174174 -
Provigil (Modafinil) Study by Taiwan Biotech Co.
|
N/A | |
| Terminated |
NCT00750919 -
Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007)
|
Phase 3 | |
| Completed |
NCT02939586 -
The Effect of Haemodialysis in Sleep Apnoea
|
N/A | |
| Completed |
NCT03075241 -
Z-Drugs for Sleep Disorders in Alzheimer's Disease
|
Phase 3 | |
| Completed |
NCT02585609 -
Sleep Quality in Patients With Advanced Cancer
|
N/A | |
| Completed |
NCT03055156 -
Effect of High Rebound Mattress Toppers on Sleep and Sleep-Related Symptoms
|
N/A | |
| Completed |
NCT01929447 -
Evaluation of WP200 With the Unified Probe (WP200U)
|
N/A | |
| Completed |
NCT01906866 -
Efficacy and Safety of Circadin® in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities
|
Phase 3 | |
| Completed |
NCT02156128 -
Subjective Memory Complaints, Objective Memory Performance and Cognitive Training
|
N/A | |
| Completed |
NCT01528462 -
Sleep Disorders Managed and Assessed Rapidly in Transient Ischemic Attack (TIA) and In Early Stroke
|
||
| Completed |
NCT01220401 -
Efficacy of a Brief Nightmare Treatment for Veterans
|
N/A | |
| Completed |
NCT01256983 -
Light for Renal Transplant Recipients Having a Sleep-Wake Dysregulation
|
Phase 0 | |
| Not yet recruiting |
NCT00749814 -
Sleep Disturbances in Hospitalized Children
|
Phase 4 | |
| Completed |
NCT00518986 -
Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Obstructive Sleep Apnea/Hypopnea and Depression
|
Phase 4 |