The Listening Program® with bone conduction headphones for Autism Spectrum Disorder
Childrens's Health Specialty Center Richardson, Richardson, TX
Targeting 2 different conditionsThe Listening Program® with bone conduction headphonesN/AWaitlist AvailableLed by Suzanne VercontaireResearch Sponsored by Children's HealthEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Auditory SOR defined by 'Some Problems or Definite Dysfunction' on the Hearing section on the Sensory Processing Measure Home Form
Diagnosis of autism spectrum disorder
Must not have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upto be administered at baseline, 1-week following a 40-week use of the listening program, and 3-months following treatment
Awards & highlights
No Placebo-Only Group
Study Summary
This trial will test the efficacy of The Listening Program in children with ASD by measuring changes in adaptive life skills and behavioral responses.
Eligible Conditions
- Autism Spectrum Disorder
- Autism
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have been identified as having some hearing problems or definite hearing dysfunction on a sensory processing assessment.
Select...
You have been diagnosed with autism spectrum disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ to be administered at baseline, 1-week following a 40-week use of the listening program, and 3-months following treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~to be administered at baseline, 1-week following a 40-week use of the listening program, and 3-months following treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline Adaptive Behavior Assessment System, Third Edition (ABAS-3) Score at 41 Weeks (Immediately Post-Treatment)
Secondary outcome measures
Pediatric Evaluation of Disability Inventory Computer Adaptive Test with ASD Scales (PEDI-CAT (ASD))
Other outcome measures
Autism Treatment Evaluation Checklist (ATEC)
Sensory Processing Measure™ (SPM™)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: The Listening Program® with bone conduction headphonesExperimental Treatment1 Intervention
The Listening Program ® Spectrum music requires a person listen to psycho-acoustically modified classical music online using specialized "Waves" ™ headphones. The headphones transmit sound through bone conduction which provides another mode of perceiving sound (https://advancedbrain.com). The Listening Program ® can be carried out in the home environment with either the base schedule, two fifteen minute sessions at least 30 minutes apart, or a condensed schedule for 30 minutes.
Bone conduction allows the listening experience to go deeper into the vestibular system which is purported to reduce stress, help regulate the "fight or flight" response, and allow the listener to achieve a state of calm and relaxed alertness. This theory is based on the function of the vagus nerve, the 10th cranial nerve, which has branches that extend to the eardrum. Stimulation of the vagus nerve stimulates the parasympathetic nervous system (Allen, 2008).
Find a site
Who is running the clinical trial?
Children's HealthLead Sponsor
6 Previous Clinical Trials
651 Total Patients Enrolled
Suzanne VercontairePrincipal Investigator
Children's HealthMedia Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have registered for this research project?
"Affirmative, the information on clinicaltrials.gov indicates that this research trial is presently searching for participants. It was initially posted on June 13th 2022 and has been recently updated as of August 3rd 2022. There are 8 spots open at one medical facility currently available to be filled."
Answered by AI
Does the age limit for inclusion in this trial extend beyond 80 years?
"This medical study is currently recruiting patients aged between 5 and 10 years of age."
Answered by AI
Is it possible to partake in this clinical examination?
"This investigation seeks to enrol 8 individuals between ages 5 and 10 with a diagnosis of autism spectrum disorder."
Answered by AI
Can individuals still participate in this clinical test?
"According to the details available on clinicaltrials.gov, this trial is presently recruiting participants for inclusion. The initial listing was posted June 13, 2022 and recently revised August 3rd of the same year."
Answered by AI
Who else is applying?
What state do they live in?
Texas
New York
Pennsylvania
Other
How old are they?
18 - 65
< 18
What site did they apply to?
Childrens's Health Specialty Center Richardson
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Email
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