Sleep and Central Auditory Processing Disorder in Autism Spectrum Disorder

NCT ID: NCT06059352

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2025-11-30

Brief Summary

The proposed study aims to understand poor sleep as a possible cause to CAPD in children and adolescents with ASD (ASD+) compared to ASD youth without CAPD (ASD-), using both caregiver-report and objective clinician administered measures. Additionally, the study will aim to understand the complex relationship between CAPD, sleep, and other associated phenotypic features of ASD such as executive and psychiatric functioning.

Detailed Description

Participation will involve one assessment session approximating 4 hours including administration of neurocognitive and socioemotional measures by trained research staff. The research team then will determine which participants meet CAPD diagnostic criteria for both the SCAN-3 and RGDT tests and assign them to the ASD+ group. Participants not meeting these criteria will be assigned to the ASD- group. Following the assessment visit, all participants will then be asked to wear actigraphy monitors (comparable to overnight polysomnography) regularly for 14 days during nighttime sleep to objectively measure sleep quality.

Conditions

Central Auditory Processing Disorder; Autism Spectrum Disorder; Sleep Disturbance

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ASD+ CAPD

This group includes children and adolescence with ASD who also have CAPD. No intervention will be applied to this group.

No interventions assigned to this group

ASD- CAPD

This group includes children and adolescence with ASD who are not affected by CAPD. No intervention will be applied to this group.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Have diagnosis of Autism Spectrum Disorder confirmed by the Autism Diagnostic Observation Schedule and the Social Communication Questionnaire, Lifetime Version which will be filled by the parent
• IQ of 50 or higher on the Abbreviated Battery IQ Score

Exclusion Criteria

• No confirmed diagnosis of Autism Spectrum Disorder
• History of sleep apnea
• History of restless leg syndrome
• History of any neurological disorders (e.g., seizures, tumors, etc.)
• Significant substance use in the past six months
• Inpatient hospitalization in the past three months-period

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Autism Speaks

OTHER

Sponsor Role: collaborator

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aarti Nair, PhD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

Loma Linda University Health

Loma Linda, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Fatimah Alramadhan, DrPH

Role: CONTACT

falramadhan@llu.edu

9095584000 ext. 19719

Facility Contacts

Aarti Nair, PhD

Role: primary

ANair@llu.edu

909-558-8707

Other Identifiers

5210160

Identifier Type: -

Identifier Source: org_study_id