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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
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