Study to evaluate whether Melatonin can help children with Autism who have trouble sleeping

Evaluation of the effectiveness of Melatonin Supplementation in children on the Autism Spectrum with Sleep Disorder

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-3hvvcqk

Enrollment

Unknown

Registered

2025-10-20

Start date

2024-12-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep disorder, unspecified

Interventions

This is a randomized, controlled, double blind clinical trial with two arms, totaling 30 participants, with 15 children allocated to each group. All participants are children with Autism Spectrum Diso

and (2) behavioral therapy associated with sleep combined with melatonin supplementation, in which participants will receive behavioral therapy focused on sleep hygiene combined with melatonin supplem

blinding will be conducted in a double blind manner so that neither the researchers nor the participants or their caregivers will know which group the child belongs to

and participants will be monitored weekly through caregiver interviews and the administration of sleep assessment scales

D06.472.506

Eligibility

Age

4 Years to 12 Years

Inclusion criteria

Inclusion criteria: Clinical diagnosis of Autism Spectrum Disorder (ASD) according to DSM-5; children aged 4 to 12 years; both sexes; not using hypnotic medications; caregivers report difficulties related to sleep quality (daytime sleepiness), time to fall asleep (delay of at least 30 minutes to fall asleep), or staying asleep (frequent night awakenings with difficulty returning to sleep); verbal IQ above 50, using the Wechsler Intelligence Scale for Children

Exclusion criteria

Exclusion criteria: Patients using hypnotic medications; with other complex medical conditions such as epilepsy, schizophrenia, or multiple sclerosis; diagnosed with oppositional defiant disorder

Design outcomes

Primary

Measure	Time frame
Expected Outcome:It is expected to find an average reduction of at least 30 minutes in sleep onset latency and a minimum increase of 10% in sleep efficiency in the experimental group compared to the placebo group The outcome will be assessed through the Children's Sleep Habits Questionnaire (Abbreviated) – CSHQ-A and sleep diaries completed by caregivers The following parameters will be observed: sleep onset latency (minutes), total sleep duration (hours), number of nighttime awakenings (count), and sleep efficiency (percentage) Measurements will be conducted at baseline and after 8 weeks of intervention, allowing for comparison between groups and determination of the intervention’s efficacy	—

Measure

Time frame

Expected Outcome:It is expected to find an average reduction of at least 30 minutes in sleep onset latency and a minimum increase of 10% in sleep efficiency in the experimental group compared to the placebo group The outcome will be assessed through the Children's Sleep Habits Questionnaire (Abbreviated) – CSHQ-A and sleep diaries completed by caregivers The following parameters will be observed: sleep onset latency (minutes), total sleep duration (hours), number of nighttime awakenings (count), and sleep efficiency (percentage) Measurements will be conducted at baseline and after 8 weeks of intervention, allowing for comparison between groups and determination of the intervention’s efficacy

—

Secondary

Measure	Time frame
No secondary outcomes are expected	—

Countries

Brazil

Contacts

Public ContactRodrigo Vieira

Universidade de Brasília - PPG- Ciências Médicas - Faculdade de Medicina

vieirarodrigogabriel@gmail.com+5561992996482

Outcome results

None listed

Source: REBEC (via WHO ICTRP)