Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT01993251
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
12 Years
Study:
NCT01993251
Study Brief:
Protocol Section:
NCT01993251