Sleep and Central Auditory Processing Disorder in Autism Spectrum Disorder

NCT06059352 | Recruiting

• 1 other identifier: 5210160
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Auditory Processing Disorder; Autism Spectrum Disorder; Sleep Disturbance

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead
• Autism Speaks: collaborator

Study Sites (1)

Loma Linda University Health

Loma Linda, California, 92350, United States

RECRUITING

MeSH Terms

Conditions

Language Development Disorders; Autism Spectrum Disorder; Parasomnias

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Sleep Wake Disorders

Study Officials

• Aarti Nair, PhD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatimah Alramadhan, DrPH

CONTACT

9095584000; falramadhan@llu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)