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

Part of paid clinical trials in Richardson, Texas.

Sponsor
Children's Health
Study ID
NCT05009095
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 10 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Jun 13, 2022
Status verified
Jan 2026
Primary completion
Jun 11, 2024
Completion
Jun 11, 2024

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: The Listening Program® with bone conduction headphones
    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).

Primary Outcome Measure

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. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Childrens's Health Specialty Center RichardsonRichardsonTexas75082-

Find similar trials in Richardson, TX

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Childrens's Health Specialty Center Richardson· Richardson, TX

Related Studies