Does Melatonin Restore Sleep Architecture in Autistic Children

Sleep Disorders Clinical Trial

— SOMELIA  

Official title:

Does Melatonin Restore Sleep Architecture in Autistic Children?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01993251
• Other study ID #: 2012-732
• Secondary ID: 2013-001230-17
• Status: Completed
• Phase: Phase 2
• Start date: June 2014
• Est. completion date: June 12, 2018

Study information

• Verified date: January 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 12, 2018
• Est. primary completion date: June 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

Inclusion Criteria:

• Boys and girls from 3 to 12 years old with autism spectrum,

• Diagnosed by psychiatrists according to the diagnostic criteria for autism ICD-10 AND ADI or ADOS positive,

• With trouble sleeping, assessed by questionnaire CHSQ,

• Having made a night polysomnography,

• Written informed consent (signed by parents),

• Affiliated with the French universal healthcare system.

Exclusion Criteria:

• Children who stopped all treatment for sleep for less than one month,

• Liver or kidney insufficiencies,

• Acute illness during or occurred in the month preceding the study,

• Neurological disease without autism spectrum , patients with non-controlled epilepsy

• Health background witch can influence sleep (other than autism itself),

• Obstructive syndrome (history - oral breathing in wakefulness, nocturnal snoring significant (heard the door closed), nocturnal respiratory effort, apnea reported by parents- and clinical examination (chronic nasal congestion, large tonsils and touching),

• Known hypersensitivity to the active substance or to one of the excipient contained in the verum or in the placebo,

• Children under treatment against-indicated with the study treatment witch can't be stopped

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorders
• Sleep Wake Disorders

Intervention

Drug:
• melatonin
one capsule, melatonin 0.5 mg, oral, once a day, 30 minutes before bedtime
• Melatonin
one capsule, melatonin 2 mg, oral, once a day, 30 minutes before bedtime
• Melatonin
one capsule, melatonin 6 mg, oral, once a day, 30 minutes before bedtime
• placebo
one capsule, placebo, oral, once a day, 30 minutes before bedtime

Locations

Country	Name	City	State
France	Hôpital Femme Mere Enfant	Bron
France	CHU de Caen	Caen
France	Centre Hospitalier du Chinonais	Chinon
France	CHRU de Strasbourg	Strasbourg
France	CHU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the most effective dose of melatonin to improve sleep quality in autistic children.	The primary outcome is to measure the awakenings index which is the number of nocturnal awakenings higher than 15 seconds per hour of sleep measured by polysomnography.	The primary outcome will be assessed once at V2 (D29 +/- 7days) by polysomnography.
Secondary	To assess in autistic children the melatonin effects on sleep characteristics	by measuring the sleep latency	It will be assessed once at V2 (D29 +/- 7 days) by polysomnography and actimetrics.
Secondary	To assess the effectiveness of treatment on sleep disorders.	It is to evaluate the effectiveness with the scale treatment response, the sleep questionnaire and severity index of insomnia	It will be assessed once at V2 (D29 +/- 7 days) by polysomnography and actimetrics.
Secondary	To assess the effectiveness of melatonin on daytime autistic behavior	Evaluate the effectiveness with the rating scale autistic behavior.	It will be assessed three times at V1 (D0), V2 (D29 +/- 7 days) and V4 (D44+/-7days).
Secondary	To assess the melatonin safety in autistic children.	Evaluate the safety with Adverse events report.	It will be assessed three times at V2 (D29 +/- 7 days), V3(D30) and V4 (D44+/-7days).
Secondary	Establish whether there is a correlation between sleep quality and melatonin secretion.	With the urinary melatonin dosage.	It will be assessed twice at V3 (D30) and V4 (D44+/-7days).
Secondary	To assess in autistic children the melatonin effects on sleep characteristics.	by measuring the indexes arousals	at V2 (D29 +/- 7 days) by polysomnography and actimetrics.
Secondary	To assess in autistic children the melatonin effects on sleep characteristics.	by measuring time and percentage of different stages of NREM (Non rapid eye movement) and REM sleep	at V2 (D29 +/- 7 days) by polysomnography and actimetrics.
Secondary	To assess in autistic children the melatonin effects on sleep characteristics	by measuring the density of sleep spindles in light NREM sleep	at V2 (D29 +/- 7 days) by polysomnography and actimetrics
Secondary	To assess in autistic children the melatonin effects on sleep characteristics	by measuring the density of eye movements REM sleep.	at V2 (D29 +/- 7 days) by polysomnography and actimetrics.