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Search / Trial NCT06260020

Development and Validation of a Comprehensive Module for Management of Sleep Disorders in ASD Children

Launched by ALL INDIA INSTITUTE OF MEDICAL SCIENCES · Feb 13, 2024

Trial Information

Current as of August 20, 2025

Not yet recruiting

Keywords

Asd Psg Cshq Actigraphy Sleep

ClinConnect Summary

This clinical trial is focused on improving how we manage sleep disorders in children with Autism Spectrum Disorder (ASD). Sleep problems are very common in these children and can impact their overall health, behavior, and mental well-being. The study aims to create a comprehensive program that effectively addresses these sleep issues and also tests a tool called actigraphy, which can help us understand sleep patterns in children with ASD. This is especially important because traditional sleep studies, known as polysomnography (PSG), can be challenging for children with sensory sensitivities.

To participate in this study, children must be between 4 to 10 years old, diagnosed with both ASD and a specific sleep disorder, and have been receiving behavioral therapy for at least six months. The trial is not yet recruiting participants, but if eligible, families can expect to be part of a program that aims to improve their child's sleep and behavior. It's important to note that children with certain conditions, like severe epilepsy or specific genetic syndromes, will not be included in this trial.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Children aged 4-10 years with diagnosis of ASD and ICSD based sleep disorder
  • 2. At-least 6 months of behavioral therapy and follow-up at AIIMS
  • Exclusion Criteria:
  • 1. Refractory epilepsy
  • 2. Secondary causes of ASD like Fragile-X Syndrome, Down Syndrome, Tuberous sclerosis
  • 3. ASD with metabolic disorders

About All India Institute Of Medical Sciences

The All India Institute of Medical Sciences (AIIMS) is a premier medical institution and research center in India, recognized for its commitment to advancing healthcare through innovative research and clinical trials. Established with the mission to provide high-quality medical education, patient care, and groundbreaking research, AIIMS plays a pivotal role in the development and evaluation of new therapies and interventions. Its multidisciplinary approach, combined with a robust infrastructure and a team of leading healthcare professionals, positions AIIMS as a key player in the global clinical research landscape, dedicated to improving health outcomes and fostering scientific excellence.

Locations

Patients applied

0 patients applied

Trial Officials

Sheffali Gulati, MD

Principal Investigator

All India Institute of Medical Sciences

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported