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NCT05009095 · ClinicalTrials.gov registry record · NA
The Listening Program® With Bone Conduction Headphones Changes Hypersensitivity to Sound and Behavioral Responses
A NA study, sponsored by Children's Health.
- Completed
- Registry status
- NA
- Development phase
- 8
- Enrollment target
NCT05009095 is a NA study that has completed, run by Children's Health. The registered enrollment target is 8 participants.
The verdict
NCT05009095, a NA study, has completed, sponsored by Children's Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
Study 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.
Interventions
- DEVICE The Listening Program® with bone conduction headphones
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2022-06-13 |
| Est. Completion | 2024-06-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05009095
The ClinicalTrials.gov registry entry for NCT05009095 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Health, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which The Listening Program® with bone conduction headphones is the first listed.
NCT05009095 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05009095 about?
NCT05009095 is a clinical study titled "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 sen...
What is the current status of trial NCT05009095?
This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2022-06-13. Estimated completion is 2024-06-11.
What interventions are being tested in trial NCT05009095?
The interventions under investigation include: The Listening Program® with bone conduction headphones (DEVICE).
Who is sponsoring clinical trial NCT05009095?
This trial is sponsored by Children's Health, which has 4 total clinical trials registered on ClinicalTrials.gov.
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