Sleep and Central Auditory Processing Disorder in Autism Spectrum Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-17
SponsorLoma Linda University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.)
Trial population
One hundred school-aged children and adolescents with ASD who are between the ages of 6-17 years old.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsGroup A: ASD+ CAPD
Group B: ASD- CAPD
Trial outcomes
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 year2
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 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Loma Linda University
Lead sponsor
Autism Speaks
Collaborator
Source ClinicalTrials.gov