What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Sound-based interventions for Autism Spectrum Disorder (ASD), such as The Listening Program® Spectrum music with Waves™ (bone conduction) headphones, generally have minimal side effects. These interventions aim to reduce auditory sensory over-responsivity (SOR) and improve adaptive life skills. Common side effects, if any, may include temporary discomfort or increased sensitivity to sound during the initial phase of treatment. Broader ASD treatments, such as behavioral therapies and medications, can have side effects ranging from mild (e.g., irritability, sleep disturbances) to more severe (e.g., gastrointestinal issues, weight gain, and in rare cases, increased risk of seizures). It is important to monitor and discuss any side effects with a healthcare provider.

What prior FDA approvals exist?

Currently, there are no FDA-approved drugs specifically targeting auditory sensory over-responsivity (SOR) in Autism Spectrum Disorder (ASD) similar to the sound-based intervention using low frequency music described in The Listening Program® Spectrum music with Waves™ (bone conduction) headphones. The FDA has approved medications like risperidone and aripiprazole for the treatment of irritability associated with ASD, but these do not specifically address auditory SOR. Other non-pharmacological interventions, such as behavioral therapies, are commonly used to manage various symptoms of ASD.

What other types of research exist?

Promising alternatives to The Listening Program® Spectrum music with Waves™ headphones for treating auditory SOR in ASD patients include: 1) Guided Internet-Based Cognitive Behavioral Therapy (CBT) for auditory hypersensitivity, which has shown effectiveness in reducing distress associated with auditory stimuli. 2) Noise-attenuating headphones combined with systematic desensitization therapy, which aims to gradually reduce sensitivity to auditory stimuli. 3) Advanced sound-based therapies such as auditory integration training (AIT) and therapeutic listening programs that use a variety of sound frequencies and patterns to improve auditory processing and reduce hypersensitivity.

← Back to Search

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

No Placebo-Only Group

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

Select...

My child is between 5 and 10 years old.

Select...

I have been diagnosed with autism spectrum disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with a seizure disorder.

Select...

I have a hearing problem.

Select...

I have Fragile X syndrome or another genetic disease.

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

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™)

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

The Listening Program® with bone conduction headphones

2022

N/A

~10

0 / 5Eligibility criteria met

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.