The Listening Program® With Bone Conduction Headphones Changes Hypersensitivity to Sound and Behavioral Responses

NCT05009095 | Completed Results FDA Device

• 1 other identifier: STU-2019-1698
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

There are limited approaches to specifically address auditory sensory over- and under-responsivity (SOR) in children with Autism Spectrum Disorder (ASD). Exposure therapy (or systematic desensitization) may be a treatment option; researchers are investigating this approach. Many children receive sensory integration therapy, but this approach does not specifically target auditory SOR. Some families are advised to have their children avoid noxious stimuli or use compensatory techniques such as wearing headphones or ear plugs. While preliminary research suggests that use of noise attenuating headphones may reduce sympathetic activation for children with ASD and auditory SOR, this approach does not seek to change or alter the underlying cause of sympathetic activation (Pfeiffer et al., 2019). Sound-based interventions are promising options to treat hyperacusis and subsequent auditory SOR in children with ASD. The objective of this study is to investigate changes in adaptive life skills and behavioral responses in children with ASD using Advanced Brain Technology's The Listening Program ® Spectrum music utilizing Waves ™ (bone conduction) headphones. Our study will investigate the effects of a sound-based intervention developed in 2012 to specifically address the needs of children with ASD and children with hyperacusis and/or auditory SOR - The Listening Program® Spectrum music utilizing Waves™ (bone conduction) headphones by Advanced Brain Technologies. This program emphasizes low frequency music over an extended period of time; the duration recommended by Advanced Brain Technologies is 40 weeks.

Conditions

Autism Spectrum Disorder

Keywords

ASD; The Listening Program® with bone conduction headphones; Hypersensitivity to sound and behavioral responses

Outcome Measures

Primary Outcomes (1)

• Change From Adaptive Behavior Assessment System, Third Edition Score (ABAS-3) Score

  The ABAS-3 measures adaptive skills and provides a General Adaptive Composite, which is the overall score summarizing an individual's adaptive functioning. The ABAS-3 is a norm-referenced test and the General Adaptive Composite is a standard score with a mean of 100 and a standard deviation of 15, with practical score ranges typically from \~40 to \~160. Higher scores represent improvement, or higher levels of function; lower scores represent lower levels of function. Scores between 90 - 109 are considered to be average, scores between 80 - 89 are below average, scores between 71 - 79 are low, and scores of 70 or less are extremely low.

  To be administered at baseline, 1-week following a 40-week use of the listening program, and 3-months following treatment.

Secondary Outcomes (1)

• Pediatric Evaluation of Disability Inventory Computer Adaptive Test With ASD Scales (PEDI-CAT (ASD))

  To be administered at baseline, 1-week following a 40-week use of the listening program, and 3-months following treatment

Other Outcomes (2)

• Sensory Processing Measure™ (SPM™)

  To be administered at baseline, 1-week following a 40-week use of the listening program, and 3-months following treatment

• Autism Treatment Evaluation Checklist (ATEC)

  To be administered at baseline, 1-week following a 40-week use of the listening program, and 3-months following treatment

Study Arms (1)

The Listening Program® with bone conduction headphones

EXPERIMENTAL

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).

Device: The Listening Program® with bone conduction headphones

Interventions

The Listening Program® with bone conduction headphones DEVICE

The Listening Program method of Music-Based Auditory Stimulation is enhanced with the addition of bone conduction technology with the ABT Bone Conduction System. Bone Conduction combines the experience of listening to music through modified headphones adding subtle, synchronized acoustic vibration of the skin and skeletal system, engaging the whole body and brain in the listening process. This multi-sensory approach accelerates and expands the benefits of The Listening Program.

The Listening Program® with bone conduction headphones

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \. Children will be eligible to participate in this study if they are:
• Between the ages of 5 and 10 years old
• Diagnosis of autism spectrum disorder
• Auditory SOR defined by "Some Problems or Definite Dysfunction" on the Hearing section on the Sensory Processing Measure Home Form.
• Caregiver must be available to supervise listening sessions at home
• English Speaking

You may not qualify if:

• \. Children will be excluded from the study if they are:
• a. Diagnosed with seizure disorder b. Hearing impairments c. Cerebral palsy d. Fragile X syndrome or genetic disease e. Previous use of a listening base system f. Non-English speakers

Sponsors & Collaborators

• Children's Health: lead

Study Sites (1)

Childrens's Health Specialty Center Richardson

Richardson, Texas, 75082, United States

Location

Related Publications (1)

• Kramer JM, Liljenquist K, Coster WJ. Validity, reliability, and usability of the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test for autism spectrum disorders. Dev Med Child Neurol. 2016 Mar;58(3):255-61. doi: 10.1111/dmcn.12837. Epub 2015 Jun 22.

  PMID: 26104112 BACKGROUND

Related Links

• The effectiveness of auditory stimulation with Autism Spectrum Disorders: A case-control study
• Neural Mechanisms Involved in Hypersensitive Hearing: Helping Children with ASD Who Are Overly Sensitive to Sound.
• A Pilot Study of Integrated Listening Systems for Children With Sensory Processing Problems

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Suzanne Vercontaire, OT
• Organization: Children's Health

suzanne.vercontaire@childrens.com

469-488-7300

Study Officials

• Suzanne Vercontaire

  Children's Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Occupational Therapist III

Model Details: The study will use a nonconcurrent AB multiple baseline design, with A representing the baseline phase and B representing the intervention phase with a postintervention non-treatment phase.

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 17, 2021
• Study Start: June 13, 2022
• Primary Completion: June 11, 2024
• Study Completion: June 11, 2024
• Last Updated: February 23, 2026
• Results First Posted: February 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)