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Does Melatonin Restore Sleep Architecture in Autistic Children (SOMELIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01993251
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Sleep Disorders Drug: melatonin Drug: Melatonin Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Melatonin Restore Sleep Architecture in Autistic Children?
Actual Study Start Date : June 2014
Actual Primary Completion Date : June 12, 2018
Actual Study Completion Date : June 12, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Active Comparator: melatonin 0.5mg Drug: melatonin
one capsule, melatonin 0.5 mg, oral, once a day, 30 minutes before bedtime

Active Comparator: melatonin 2mg Drug: Melatonin
one capsule, melatonin 2 mg, oral, once a day, 30 minutes before bedtime

Active Comparator: melatonin 6mg Drug: Melatonin
one capsule, melatonin 6 mg, oral, once a day, 30 minutes before bedtime

Placebo Comparator: placebo Drug: placebo
one capsule, placebo, oral, once a day, 30 minutes before bedtime




Primary Outcome Measures :
  1. To determine the most effective dose of melatonin to improve sleep quality in autistic children. [ Time Frame: The primary outcome will be assessed once at V2 (D29 +/- 7days) by polysomnography. ]
    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.


Secondary Outcome Measures :
  1. To assess in autistic children the melatonin effects on sleep characteristics [ Time Frame: It will be assessed once at V2 (D29 +/- 7 days) by polysomnography and actimetrics. ]
    by measuring the sleep latency

  2. To assess the effectiveness of treatment on sleep disorders. [ Time Frame: It will be assessed once at V2 (D29 +/- 7 days) by polysomnography and actimetrics. ]
    It is to evaluate the effectiveness with the scale treatment response, the sleep questionnaire and severity index of insomnia

  3. To assess the effectiveness of melatonin on daytime autistic behavior [ Time Frame: It will be assessed three times at V1 (D0), V2 (D29 +/- 7 days) and V4 (D44+/-7days). ]
    Evaluate the effectiveness with the rating scale autistic behavior.

  4. To assess the melatonin safety in autistic children. [ Time Frame: It will be assessed three times at V2 (D29 +/- 7 days), V3(D30) and V4 (D44+/-7days). ]
    Evaluate the safety with Adverse events report.

  5. Establish whether there is a correlation between sleep quality and melatonin secretion. [ Time Frame: It will be assessed twice at V3 (D30) and V4 (D44+/-7days). ]
    With the urinary melatonin dosage.

  6. To assess in autistic children the melatonin effects on sleep characteristics. [ Time Frame: at V2 (D29 +/- 7 days) by polysomnography and actimetrics. ]
    by measuring the indexes arousals

  7. To assess in autistic children the melatonin effects on sleep characteristics. [ Time Frame: at V2 (D29 +/- 7 days) by polysomnography and actimetrics. ]
    by measuring time and percentage of different stages of NREM (Non rapid eye movement) and REM sleep

  8. To assess in autistic children the melatonin effects on sleep characteristics [ Time Frame: at V2 (D29 +/- 7 days) by polysomnography and actimetrics ]
    by measuring the density of sleep spindles in light NREM sleep

  9. To assess in autistic children the melatonin effects on sleep characteristics [ Time Frame: at V2 (D29 +/- 7 days) by polysomnography and actimetrics. ]
    by measuring the density of eye movements REM sleep.



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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993251


Locations
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France
Hôpital Femme Mere Enfant
Bron, France, 69677
CHU de Caen
Caen, France, 14033
Centre Hospitalier du Chinonais
Chinon, France
CHRU de Strasbourg
Strasbourg, France, 67091
CHU de Tours
Tours, France, 37044
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Patricia Franco, MD CHU Hôpital Femme Mère Enfant.Bron
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01993251    
Other Study ID Numbers: 2012-732
2013-001230-17 ( EudraCT Number )
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hospices Civils de Lyon:
sleep,melatonin,autism,children
Additional relevant MeSH terms:
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Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants