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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, NEW DELHI · Feb 13, 2024

Trial Information

Current as of May 06, 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, New Delhi

The All India Institute of Medical Sciences (AIIMS) in New Delhi is a premier medical research institution and a leading clinical trial sponsor in India. Renowned for its commitment to advancing healthcare through innovative research, AIIMS plays a pivotal role in conducting high-quality clinical trials across various medical disciplines. The institute is dedicated to enhancing patient care by integrating cutting-edge scientific research with clinical practice, ensuring rigorous adherence to ethical standards and regulatory guidelines. With a team of expert researchers and state-of-the-art facilities, AIIMS fosters collaboration and knowledge exchange to address pressing health challenges and contribute to global medical advancements.

Locations

Patients applied

0 patients applied

Trial Officials

Sheffali Gulati, MD

Principal Investigator

All India Institute of Medical Sciences, New Delhi

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported