Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06059352

Sleep and Central Auditory Processing Disorder in Autism Spectrum Disorder

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Central Auditory Processing Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Communication Disorders Language Development Disorders Language Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disturbance Sleep Wake Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Loma Linda University Health

Loma Linda, California, 92350, United States

Location status: Recruiting

Location contact

Aarti Nair, PhD

CONTACT

[email protected]

909-558-8707

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sensory Processing Patterns in Children Ages 14 and Below

    Time frame: Through study completion, an average of one year

    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.

  2. Sensory Processing Patterns in Children Ages 15 and Above

    Time frame: Through study completion, an average of one year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fatimah Alramadhan, DrPH

CONTACT

[email protected]

9095584000 ext. 19719

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Collaborators

  • Autism Speaks

Registry information

Official study title

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

Acronym: ASD

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 28, 2023
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.