NCT05009095

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Children's Health · Academic / Other
• Sex: All
• Age: 5 Years – 10 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DEVICE	The Listening Program® with bone conduction headphones	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.

Timeline

• Start date: 2022-06-13
• Primary completion: 2024-06-11
• Completion: 2024-06-11
• First posted: 2021-08-17
• Last updated: 2026-02-23
• Results posted: 2026-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study