Sleep and Central Auditory Processing Disorder in Autism Spectrum Disorder (ASD)

Contribution of Central Auditory Processing Disorder (CAPD) to Sleep Disturbances in Autism Spectrum Disorder (ASD)

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Disturbance; Autism Spectrum Disorder; Central Auditory Processing Disorder

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Fatimah Alramadhan, DrPH; Phone Number: 19719 9095584000; Email: falramadhan@llu.edu

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Recruiting
      • Loma Linda University Health
      • Contact: Aarti Nair, PhD; Phone Number: 909-558-8707; Email: ANair@llu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

One hundred school-aged children and adolescents with ASD who are between the ages of 6-17 years old.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
ASD+ CAPD; This group includes children and adolescence with ASD who also have CAPD. No intervention will be applied 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory Processing Patterns in Children Ages 14 and Below	Sensory sensitivity is a composite measurement using the 86 item Sensory Profile 2 (SP-2). SP-2 has 4 quadrants; Seeking (degree child obtains sensory input); Avoiding (degree child is bothered by sensory input); Sensitivity ( degree child detects sensory input); Registration (degree child misses sensory input). SP-2 is completed by parents of subjects using a scale of 5 (almost always = 90% or more), 4 (frequently= 75% of the time), 3 (half of the time = 50%), 2 (occasionally= 25%), 1 (almost never = 10% or less), or does not apply. Seeking quadrant normal limits are 20-47; elevated seeking scores are ≥ 48, reduced seeking behaviors are ≤ 19. Avoiding quadrant normal limits are 21-46; elevated avoiding scores are ≥ 47; reduced avoiding scores are ≤ 20. Sensitivity quadrant normal limits are 18- 42; elevated scores are ≥ 43; reduced scores are ≤ 17 and below. Registration quadrant normal limits are 19-43; elevated scores are ≥ 44; reduced scores are ≤18.	Through study completion, an average of one year
Sensory Processing Patterns in Children Ages 15 and Above	Sensory sensitivity is a composite measurement using the 60-item adolescent/ adult sensory profile (AASP). AASP has 4 quadrants: Low Registration, Sensation Seeking, Sensitivity; Avoiding. Subjects will respond using a scale of almost never (5% or less of the time), seldom (25% of the time), occasionally (50% of the time), frequently (75% of the time), and almost always (95% or more of the time). Low Registration normal limits are 27-40; elevated scores are ≥ 41; reduced registration scores are ≤ 26. Sensation seeking normal limits are 42-58; elevated sensation scores are ≥ 59; reduced sensation scores are ≤ 25. Sensitivity normal limits are 26-40; elevated sensitivity scores are ≥ 41; reduced scores are ≤ 25. Avoiding normal limits are 26-40; elevated scores are ≥ 41; reduced scores are ≤ 25.	Through study completion, an average of one year

Collaborators and Investigators

• Sponsor: Loma Linda University
• Collaborators: Autism Speaks
• Investigators: Principal Investigator: Aarti Nair, PhD, Loma Linda University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: September 27, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Sleep Wake Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Communication Disorders; Language Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Autism Spectrum Disorder; Parasomnias; Language Development Disorders
• Other Study ID Numbers: 5210160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No