Central Auditory Processing DisorderASDNCT06059352
Sleep and Central Auditory Processing Disorder in Autism Spectrum Disorder
An observational study of Central Auditory Processing Disorder and Autism Spectrum Disorder, run by Loma Linda University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Central Auditory Processing Disorder, Autism Spectrum Disorder, Sleep Disturbance
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: One hundred school-aged children and adolescents with ASD who are between the ages of 6-17 years old.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Loma Linda University Health
Loma Linda, California, 92350
Aarti Nair, PhD, 909-558-8707, ANair@llu.edu
About this study
Official title: 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.
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.
- Medical subject headings
- Language Development Disorders, Autism Spectrum Disorder, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Nov 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Auditory Processing DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- Autism Speaks
- Responsible party
- Sponsor
- Investigators
- Aarti Nair, PhD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059352
- Sponsor's protocol ID
- 5210160
- Acronym
- ASD
- Status last verified
- Feb 2026
- First submitted
- 21 Sep 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Central Auditory Processing Disorder (CAPD) to Sleep Disturbances in Autism Spectrum Disorder (ASD)
- ClinicalTrials.gov ID
- NCT06059352
- Acronym / sponsor ID
- ASD / 5210160
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- Autism Speaks
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- One hundred school-aged children and adolescents with ASD who are between the ages of 6-17 years old.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aarti Nair, PhD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Auditory Processing Disorder and Autism Spectrum Disorder, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatimah Alramadhan, DrPH (9095584000 ext. 19719, falramadhan@llu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory Processing Patterns in Children Ages 14 and Below (time frame: Through study completion, an average of one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.