Chronobiological signatures and melatonin interventions in Autism Spectrum Disorder - ASD: sleep, inflammation, and sensory processing

Changes in sleep–wake rhythm and behavior in Autism

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

REBEC

Registry ID

RBR-6vnpb2s

Enrollment

150

Registered

2026-03-11

Start date

2026-03-02

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Sleep

Interventions

his is a non-randomized, placebo-controlled clinical intervention trial with a before-and-after (pre-post) design, conducted with children with Autism Spectrum Disorder, in which chronobiological, sle

Eligibility

Age

4 Years to 18 Years

Inclusion criteria

Inclusion criteria: Individuals aged between 4 and 18 years with a neurological and/or psychiatric diagnosis of Autism Spectrum Disorder (ASD), established according to the DSM-5-TR criteria

Exclusion criteria

Exclusion criteria: Not using beta-blockers or other medications that affect the synthesis and release pathways of melatonin; Not using melatonin.

Design outcomes

Primary

Measure	Time frame
It is expected that melatonin treatment will help synchronize sleep parameters in children with Autism Spectrum Disorder who have sleep disorders.	—

Secondary

Measure	Time frame
It is hoped that improved sleep will help bring about behavioral change in this population.	—

Countries

Contacts

Public ContactMaria Clara ;Luciana Couto;Pinato

Universidade Estadual Paulista;Universidade Estadual Paulista

clara.couto@unesp.br;luciana.pinato@unesp.br+55 (14) 3402-1324;+55 (14) 3402-1324

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Apr 4, 2026