ClinicalTrials.gg
RecruitingNCT06059352ASDUpdated Feb 4, 2026

Sleep and Central Auditory Processing Disorder in Autism Spectrum Disorder

An observational study in Central Auditory Processing Disorder, Autism Spectrum Disorder and Sleep Disturbance, sponsored by Loma Linda University. Recruiting at 1 site in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-02-04.

Sponsored by Loma Linda University · Observational

From the registry’s dates

  • Started Nov 2023; still recruiting 3 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
6 Years to 17 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Central Auditory Processing Disorder
  • Autism Spectrum Disorder
  • Sleep Disturbance
03

In context

Language Development Disorders

121 studies on the registry are indexed under Language Development Disorders; 49 are open to participants now.

This study's planned enrollment of 100 is below the median of 131 across 15 observational studies indexed under Language Development Disorders.

Browse Language Development Disorders studies →

Lead sponsor

Loma Linda University is the lead sponsor of 306 studies on the registry; 46 are open to participants now.

Of its 29 completed or terminated interventional studies of FDA-regulated products, 23 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2023 (actual). Primary completion is estimated for Dec 2026, 37 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2023
First posted
Sep 28, 2023
StartActual
Nov 1, 2023
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Feb 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06059352
Collaborators
Autism Speaks
Responsible party
Sponsor
First posted
Sep 28, 2023
Start date
Nov 1, 2023
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Feb 4, 2026

Study contacts

Fatimah Alramadhan, DrPH
Contact
falramadhan@llu.edu
9095584000 ext. 19719
Aarti Nair, PhD
principal investigator · Loma Linda University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion