Skip to main content
OpenTrials
Completed

NCT Number: NCT05009095

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Childrens's Health Specialty Center Richardson

Richardson, Texas, 75082, United States

About this study

Children with a diagnosis of ASD with auditory SOR to sound, ages 5 to 10 years, will be the primary patient population. 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. At baseline (A), demographic information will be collected and the following outcome measures will be completed: the Pediatric Evaluation of Disability Inventory Computer Adaptive Test with ASD Scales (PEDI CAT- ASD), Sensory Processing Measure (SPM) home form, the Adaptive Behavioral Assessment System 3rd Edition ABAS-3 and Autism Treatment Evaluation Checklist (ATEC). During the intervention (B) phase, parents of participants in the treatment group will be educated by the investigators on use of The Listening Program at home, and then participants in this group will receive treatment at home utilizing The Listening Program for 40 weeks. Testing, using the same 4 outcome measures, will be completed at the 41st week after use, and then again after 3 months of no treatment. Between testing sessions, caregivers and investigators will set up three phone or hospital-approved virtual platform meetings at approximately 10 week intervals to check in and answer questions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

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

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

    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.

Secondary outcomes

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

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

    The PEDI-CAT measures functional abilities, and the ASD module has been adapted for use with children and youth with ASD. This study used the Daily Activities and Social/Cognitive domains of the PEDI-CAT (ASD). The PEDI-CAT (ASD) provides a scaled score (converted from raw responses using domain-specific (IRT) item-response parameters) for each domain - this score is not norm-referenced, so does not compare children to same-aged peers. For each domain, the minimum scaled score is 20 and the maximum is 80. Higher scores represent improvement, or higher levels of function; lower scores represent lower levels of function.

Other outcomes

  1. Sensory Processing Measure™ (SPM™)

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

    The Sensory Processing Measure (SPM) measures sensory integration/sensory processing. This study used the Home Form, which gathered information about participants' behavior, coordination, and participation at home. The SPM provides a Total Sensory System score, which is an overall score summarizing an individual's sensory processing. The SPM is a norm-referenced test and the Total Sensory System score is a T-score with a mean of 50 and a standard deviation of 10 (scale range- 20 to 80). Lower scores represent improvement, or less sensory dysfunction; higher scores represent higher levels of sensory dysfunction. Scores between 40 - 59 represent typical performance, scores between 60 - 69 represent some problems, and scores between 70 - 80 represent a definite dysfunction with sensory processing.

  2. Autism Treatment Evaluation Checklist (ATEC)

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

    The ATEC is a 77-item assessment tool developed at the Autism Research Institute. It was developed to provide a free, easily accessible, and valid tool to measure changes in ASD symptoms over time. The ATEC consists of four subtest scales: Speech/Language/Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical Behavior. The four subscale scores are used to calculate a total score (77 items - score range 0 to 180). A lower score indicates less severe symptoms of ASD and a higher score correlates with more severe symptoms of ASD. Baseline scores can be compared with post-intervention scores to assist with determining intervention efficacy.

Sponsors and collaborators

Lead sponsor

Children's Health

Other

Registry information

Official study title

The Listening Program With Bone Conduction Headphones Changes Hypersensitivity to Sound and Behavioral Responses Associated With Flight/Fight Responses of Children With Autism Spectrum Disorder Therefore Increasing Adaptive Life Skills

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 17, 2021
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.