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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | To be administered at baseline, 1-week following a 40-week use of the listening program, and 3-months following treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensory Processing Measure™ (SPM™) | The Sensory Processing Measure (SPM) measures sensory integration/sensory processing. This study used the Home Form, which gathered information about participants' behavior, coordination, and participation at home. The SPM provides a Total Sensory System score, which is an overall score summarizing an individual's sensory processing. The SPM is a norm-referenced test and the Total Sensory System score is a T-score with a mean of 50 and a standard deviation of 10 (scale range- 20 to 80). Lower scores represent improvement, or less sensory dysfunction; higher scores represent higher levels of sensory dysfunction. Scores between 40 - 59 represent typical performance, scores between 60 - 69 represent some problems, and scores between 70 - 80 represent a definite dysfunction with sensory processing. |
Inclusion Criteria:
1. Children will be eligible to participate in this study if they are:
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
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne Vercontaire | Children's Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens's Health Specialty Center Richardson | Richardson | Texas | 75082 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26104112 | Background | 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. |
| Label | URL |
|---|---|
| The effectiveness of auditory stimulation with Autism Spectrum Disorders: A case-control study | View source |
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Only children with ASD and auditory SOR ages 5 - 10 were recruited and considered enrolled for this study. Parents/caregivers are not considered enrolled and not the study subject population. Flyers were posted at the system's outpatient rehabilitation and therapy clinics and also given to parents of children who met inclusion criteria and interested in the study. Some parents learned about the study from ClinicalTrials.gov and reached out to study team to request participation in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Only Children with ASD and auditory SOR ages 5 - 10 were recruited and considered enrolled for this study. Parents/caregivers are not considered enrolled and not the study subject population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data required to analyze this outcome not collected from one subject who was lost to follow up after Visit 1. Data from another subject was excluded from this analysis as his family did not follow treatment protocol. | Posted | Mean | Standard Deviation | score on a scale | To be administered at baseline, 1-week following a 40-week use of the listening program, and 3-months following treatment. |
|
2 years
Participants were monitored for adverse events throughout the study duration, except for one participant who was lost to follow up after Visit 1.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suzanne Vercontaire, OT | Children's Health | 469-488-7300 | suzanne.vercontaire@childrens.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 12, 2025 | Dec 9, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 27, 2021 | Dec 9, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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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.
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|
| To be administered at baseline, 1-week following a 40-week use of the listening program, and 3-months following treatment |
| To be administered at baseline, 1-week following a 40-week use of the listening program, and 3-months following treatment |
| Autism Treatment Evaluation Checklist (ATEC) | The ATEC is a 77-item assessment tool developed at the Autism Research Institute. It was developed to provide a free, easily accessible, and valid tool to measure changes in ASD symptoms over time. The ATEC consists of four subtest scales: Speech/Language/Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical Behavior. The four subscale scores are used to calculate a total score (77 items - score range 0 to 180). A lower score indicates less severe symptoms of ASD and a higher score correlates with more severe symptoms of ASD. Baseline scores can be compared with post-intervention scores to assist with determining intervention efficacy. | To be administered at baseline, 1-week following a 40-week use of the listening program, and 3-months following treatment |
| Neural Mechanisms Involved in Hypersensitive Hearing: Helping Children with ASD Who Are Overly Sensitive to Sound. | View source |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG000 | 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). |
|
|
| Secondary | 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. | Data required to analyze this outcome not collected from one subject who was lost to follow up after Visit 1. Data from another subject was excluded from this analysis as his family did not follow treatment protocol. | Posted | Mean | Standard Deviation | score on a scale | To be administered at baseline, 1-week following a 40-week use of the listening program, and 3-months following treatment |
|
|
|
| Other Pre-specified | Sensory Processing Measure™ (SPM™) | The Sensory Processing Measure (SPM) measures sensory integration/sensory processing. This study used the Home Form, which gathered information about participants' behavior, coordination, and participation at home. The SPM provides a Total Sensory System score, which is an overall score summarizing an individual's sensory processing. The SPM is a norm-referenced test and the Total Sensory System score is a T-score with a mean of 50 and a standard deviation of 10 (scale range- 20 to 80). Lower scores represent improvement, or less sensory dysfunction; higher scores represent higher levels of sensory dysfunction. Scores between 40 - 59 represent typical performance, scores between 60 - 69 represent some problems, and scores between 70 - 80 represent a definite dysfunction with sensory processing. | Data required to analyze this outcome not collected from one subject who was lost to follow up after Visit 1. Data from another subject was excluded from this analysis as his family did not follow treatment protocol. | Posted | Mean | Standard Deviation | T-score | To be administered at baseline, 1-week following a 40-week use of the listening program, and 3-months following treatment |
|
|
|
| Other Pre-specified | Autism Treatment Evaluation Checklist (ATEC) | The ATEC is a 77-item assessment tool developed at the Autism Research Institute. It was developed to provide a free, easily accessible, and valid tool to measure changes in ASD symptoms over time. The ATEC consists of four subtest scales: Speech/Language/Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical Behavior. The four subscale scores are used to calculate a total score (77 items - score range 0 to 180). A lower score indicates less severe symptoms of ASD and a higher score correlates with more severe symptoms of ASD. Baseline scores can be compared with post-intervention scores to assist with determining intervention efficacy. | Data required to analyze this outcome not collected from one subject who was lost to follow up after Visit 1. Data from another subject was excluded from this analysis as his family did not follow treatment protocol. | Posted | Mean | Standard Deviation | score on a scale | To be administered at baseline, 1-week following a 40-week use of the listening program, and 3-months following treatment |
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| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
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| Social/Cognitive, Baseline |
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| Social/Cognitive, 1-week post-treatment |
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| Social/Cognitive, 3-months post-treatment |
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