Autism Spectrum DisorderNCT05009095
The Listening Program® With Bone Conduction Headphones Changes Hypersensitivity to Sound and Behavioral Responses
A study testing The Listening Program® with bone conduction headphones in people with Autism Spectrum Disorder, run by Children's Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- The Listening Program® with bone conduction headphones
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2022to 11 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1. 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
Who cannot join
- 1. Children will be excluded from the study if they are:
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Childrens's Health Specialty Center Richardson
Richardson, Texas, 75082
About this study
Official 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
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.
Read the 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
- Being tested
- The Listening Program® with bone conduction headphones
- Keywords
- ASD, The Listening Program® with bone conduction headphones, Hypersensitivity to sound and behavioral responses
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Listening Program® with bone conduction headphonesDevice
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 group | Role | What they receive |
|---|---|---|
| The Listening Program® with bone conduction headphones | Experimental | 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). Receives: Device: The Listening Program® with bone conduction headphones |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Adaptive Behavior Assessment System, Third Edition Score (ABAS-3) Score
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.
Measured: To be administered at baseline, 1-week following a 40-week use of the listening program, and 3-months following treatment.
Secondary outcomes (1)
Pediatric Evaluation of Disability Inventory Computer Adaptive Test With ASD Scales (PEDI-CAT (ASD))
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.
Measured: To be administered at baseline, 1-week following a 40-week use of the listening program, and 3-months following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start13 Jun 2022
- Primary completion11 Jun 2024
- Study completion11 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzanne Vercontaire, Children's Health
- Investigators
- Suzanne Vercontaire, Principal investigator, Children's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009095
- Sponsor's protocol ID
- STU-2019-1698
- Status last verified
- Jan 2026
- First submitted
- 3 Aug 2021
- Last updated
- 23 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26104112
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05009095
- Acronym / sponsor ID
- STU-2019-1698
- Conditions
- Autism Spectrum Disorder
- Keywords
- ASD, The Listening Program® with bone conduction headphones, Hypersensitivity to sound and behavioral responses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Children's HealthUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 11 Jun 2024 (actual)
- Study completion
- 11 Jun 2024 (actual)
- First posted
- 17 Aug 2021 (actual)
- Results
- Posted 23 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| The Listening Program® with bone conduction headphones | Experimental | Device: The Listening Program® with bone conduction headphonesThe 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). |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Listening Program® with bone conduction headphonesThe 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. | Device | The Listening Program® with bone conduction headphones |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26104112Kramer 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.
- The effectiveness of auditory stimulation with Autism Spectrum Disorders: A case-control studyLink provided by the sponsor.
- Neural Mechanisms Involved in Hypersensitive Hearing: Helping Children with ASD Who Are Overly Sensitive to Sound.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Vercontaire principal investigator
Children's Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Listening Program® with bone conduction headphones in people with Autism Spectrum Disorder, run by Children's Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05009095, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026; AzTrials last refreshed its copy on 28 Oct 2026.