Sleep and Central Auditory Processing Disorder in Autism Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

— ASD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06059352
• Other study ID #: 5210160
• Status: Not yet recruiting
• Start date: November 2024
• Est. completion date: November 2025

Study information

• Verified date: April 2024
• Source: Loma Linda University
• Contact: Fatimah Alramadhan, DrPH
• Phone: 9095584000
• Email: falramadhan[@]llu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Auditory Perceptual Disorders
• Autism Spectrum Disorder
• Autistic Disorder
• Central Auditory Processing Disorder
• Child Development Disorders, Pervasive
• Dyssomnias
• Language Development Disorders
• Parasomnias
• Sleep Disturbance

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Loma Linda University	Autism Speaks

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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