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

NCT ID: NCT05009095

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-13
• Study Completion Date: 2024-06-11

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

The Listening Program® with bone conduction headphones

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Children will be eligible to participate in this study if they are:

1. Between the ages of 5 and 10 years old

2. Diagnosis of autism spectrum disorder

3. Auditory SOR defined by "Some Problems or Definite Dysfunction" on the Hearing section on the Sensory Processing Measure Home Form.

4. Caregiver must be available to supervise listening sessions at home

5. English Speaking

Exclusion Criteria

1. 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Health

OTHER

Sponsor Role: lead

Responsible Party

Suzanne Vercontaire

Occupational Therapist III

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suzanne Vercontaire

Role: PRINCIPAL_INVESTIGATOR

Children's Health

Locations

Childrens's Health Specialty Center Richardson

Richardson, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26104112 (View on PubMed)

Other Identifiers

STU-2019-1698

Identifier Type: -

Identifier Source: org_study_id