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The Listening Program for Autism

N/A
Waitlist Available
Led By Suzanne Vercontaire
Research Sponsored by Children's Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children between the ages of 5 and 10 years old
Diagnosis of autism spectrum disorder
Must not have
Diagnosed with seizure disorder
Hearing impairments
Timeline
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
Awards & highlights

Summary

This trial is testing a special music program using special headphones for children aged 5-10 with autism who are sensitive to sounds. The program uses special music to help their brains adjust to different sounds, aiming to reduce their sensitivity.

Who is the study for?
This trial is for children aged 5-10 with Autism Spectrum Disorder who have issues with sound sensitivity. They must speak English and have a caregiver to supervise home listening sessions. It's not suitable for kids with cerebral palsy, seizure disorders, hearing impairments, previous listening therapy, or certain genetic diseases.
What is being tested?
The study tests The Listening Program® using bone conduction headphones to see if it helps children with ASD who are overly sensitive to sounds improve their behavior and daily skills. The program uses low-frequency music over a recommended period of 40 weeks.
What are the potential side effects?
Potential side effects aren't specified in the provided information but could include discomfort from wearing headphones or unexpected behavioral changes due to new sensory experiences.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My child is between 5 and 10 years old.
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I have been diagnosed with autism spectrum disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with a seizure disorder.
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I have a hearing problem.
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I have Fragile X syndrome or another genetic disease.

Timeline

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and to be administered at baseline, 1-week following a 40-week use of the listening program, and 3-months following treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline Adaptive Behavior Assessment System, Third Edition (ABAS-3) Score at 41 Weeks (Immediately Post-Treatment)
Secondary study objectives
Pediatric Evaluation of Disability Inventory Computer Adaptive Test with ASD Scales (PEDI-CAT (ASD))
Other study objectives
Autism Treatment Evaluation Checklist (ATEC)
Sensory Processing Measure™ (SPM™)

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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
The Listening Program® with bone conduction headphones
2022
N/A
~10

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The Listening Program® Spectrum music with Waves™ (bone conduction) headphones is a sound-based intervention designed to address auditory sensory over-responsivity (SOR) in children with Autism Spectrum Disorder (ASD). This treatment uses low-frequency music delivered through bone conduction headphones over an extended period, typically 40 weeks. The mechanism of action involves systematic desensitization to auditory stimuli, which aims to reduce hypersensitivity and improve adaptive life skills and behavioral responses. This is significant for ASD patients as it targets the underlying cause of sympathetic activation, potentially leading to better management of auditory sensitivities and enhancing overall quality of life.
Comprehensive behavioral management of complex tinnitus: a case illustration.Effect of Frequency Discrimination Training on Tinnitus in Individuals with Flat Sensorineural Hearing loss.Toward a Multidimensional Understanding of Misophonia Using Cluster-Based Phenotyping.

Find a Location

Who is running the clinical trial?

Children's HealthLead Sponsor
7 Previous Clinical Trials
711 Total Patients Enrolled
Suzanne VercontairePrincipal InvestigatorChildren's Health

Media Library

The Listening Program® with bone conduction headphones Clinical Trial Eligibility Overview. Trial Name: NCT05009095 — N/A
Autism Spectrum Disorder Research Study Groups: The Listening Program® with bone conduction headphones
Autism Spectrum Disorder Clinical Trial 2023: The Listening Program® with bone conduction headphones Highlights & Side Effects. Trial Name: NCT05009095 — N/A
The Listening Program® with bone conduction headphones 2023 Treatment Timeline for Medical Study. Trial Name: NCT05009095 — N/A
~2 spots leftby Oct 2025