Auditory Perceptual DisordersNCT02398422
The Listening Project at Reiss-Davis/Vista Del Mar Child and Family Services
A study testing Listening Project Protocol in people with Auditory Perceptual Disorders and Stress Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
A research project funded by the Reiss-Davis Child Study Center of Vista Del Mar (RDCSC/VDM) will be conducted on the Vista Del Mar campus of the RDCSC/VDM to evaluate the effectiveness of the Listening Project Protocol (LPP) in children who have difficulties with autonomic and behavior regulation in the classroom. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Auditory Perceptual Disorders, Stress Disorder
- What is being tested?
- Listening Project Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children must be between ages 6-17 years
- children must be able to read/speak in English. Parents must be able to read/speak in either English or Spanish
- children must be patients, students and/or residents at Reiss-Davis/Vista del Mar
Who cannot join
- children who wear a hearing device
- children with a history of heart disease
- children who are currently being treated for a seizure disorder
- children who are non-verbal
Trial locations and contacts
1 site in 1 country.
United States1 site
Reiss-Davis / Vista del Mar Child and Family Services
Los Angeles, California, 90034
About this study
A research project funded by the Reiss-Davis Child Study Center of Vista Del Mar (RDCSC/VDM) will be conducted on the Vista Del Mar campus of the RDCSC/VDM to evaluate the effectiveness of the Listening Project Protocol (LPP) in children who have difficulties with autonomic and behavior regulation in the classroom. The LPP is designed as a "neural exercise" to reduce auditory hypersensitivities, to improve auditory processing of speech, and to improve behavioral state regulation. The LPP uses acoustic stimulation to exercise the neural regulation of the middle ear structures to rehabilitate and to normalize the acoustic transfer function of the middle ear structures. The current study is being conducted to evaluate efficacy and feasibility of the LPP with emotionally disturbed and learning challenged young people and will use objective measures to evaluate changes in acoustic transfer function of the middle ears structures, auditory processing skills, physiological state regulation, sensory symptoms, and academic pre and post testing.
- Conditions
- Auditory Perceptual Disorders, Stress Disorder
- Being tested
- Listening Project Protocol
- Keywords
- Autonomic nervous system, Auditory processing disorder, Social behavior
- Medical subject headings
- Auditory Perceptual Disorders, Stress Disorders, Traumatic, Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listening Project ProtocolBehavioural
The filtered-music intervention will consist of listening to computer-altered acoustic stimulation, designed to modulate the frequency band of vocal music passed to the participant. The frequency characteristics of the acoustic stimulation are selected to emphasize the relative importance of specific frequencies in conveying the information embedded in human speech. Modulation of the acoustic energy within the frequencies of human voice, similar to an exaggerated vocal prosody, are hypothesized to recruit and modulate the neural regulation of the middle ear muscles and to functionally reduce sound hypersensitivities and improve auditory processing.
The non-filtered music intervention will consist of the same music as the filtered-music intervention.
| Study group | Role | What they receive |
|---|---|---|
| Filtered Music Intervention | Experimental | Participants will be included in all pre-intervention and post-assessment measures. Participants will receive the Listening Project Protocol intervention (filtered music). The duration of the intervention is approximately 45 minutes per day, for 5 consecutive days. Receives: Behavioral: Listening Project Protocol |
| Nonfiltered Music Intervention | Experimental | Participants will be included in all pre-intervention and post-assessment measures. Participants will receive the Listening Project Protocol intervention (nonfiltered music). The duration of the intervention is approximately 45 minutes per day, for 5 consecutive days. Receives: Behavioral: Listening Project Protocol |
| Assessment-only | No intervention | The assessment-only group will participate in all pre- and post-intervention assessments, but will not receive the Listening Project Protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in auditory hypersensitivity at 1 week, and at 2 months
Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)
Measured: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 2 months post-intervention
Secondary outcomes (4)
Change from baseline in state regulation at 1 week, and at 2 months
heart rate, heart period, high-frequency heart rate variability/respiratory sinus arrhythmia
Measured: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention
Change from baseline in auditory processing at 1 week, and at 2 months
filtered words, competing words subscales of SCAN
Measured: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention
Change from baseline in social behavior at 1 week, and at 2 months
Listening Project Parent Questionnaire
Measured: post-intervention (within 1 week after the intervention), 2 months post-intervention
Change from baseline in middle ear transfer function at 1 week, and at 2 months
Middle Ear Sound Absorption System (MESAS)
Measured: post-intervention (within 1 week after the intervention), 2 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auditory Perceptual DisordersStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Reiss-Davis Child Study Center of Vista Del Mar
- Responsible party
- Sponsor
- Investigators
- Keri J Heilman, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398422
- Sponsor's protocol ID
- 14-3268
- Status last verified
- Aug 2021
- First submitted
- 16 Mar 2015
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Listening Project at Reiss-Davis/Vista Del Mar Child and Family Services
- ClinicalTrials.gov ID
- NCT02398422
- Acronym / sponsor ID
- 14-3268
- Conditions
- Auditory Perceptual Disorders, Stress Disorder
- Keywords
- Autonomic nervous system, Auditory processing disorder, Social behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Reiss-Davis Child Study Center of Vista Del Mar
- Study start
- Oct 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 25 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A research project funded by the Reiss-Davis Child Study Center of Vista Del Mar (RDCSC/VDM) will be conducted on the Vista Del Mar campus of the RDCSC/VDM to evaluate the effectiveness of the Listening Project Protocol (LPP) in children who have difficulties with autonomic and behavior regulation in the classroom. The LPP is designed as a "neural exercise" to reduce auditory hypersensitivities, to improve auditory processing of speech, and to improve behavioral state regulation. The LPP uses acoustic stimulation to exercise the neural regulation of the middle ear structures to rehabilitate and to normalize the acoustic transfer function of the middle ear structures. The current study is being conducted to evaluate efficacy and feasibility of the LPP with emotionally disturbed and learning challenged young people and will use objective measures to evaluate changes in acoustic transfer function of the middle ears structures, auditory processing skills, physiological state regulation, sensory symptoms, and academic pre and post testing.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Filtered Music Intervention | Experimental | Behavioral: Listening Project ProtocolParticipants will be included in all pre-intervention and post-assessment measures. Participants will receive the Listening Project Protocol intervention (filtered music). The duration of the intervention is approximately 45 minutes per day, for 5 consecutive days. |
| Nonfiltered Music Intervention | Experimental | Behavioral: Listening Project ProtocolParticipants will be included in all pre-intervention and post-assessment measures. Participants will receive the Listening Project Protocol intervention (nonfiltered music). The duration of the intervention is approximately 45 minutes per day, for 5 consecutive days. |
| Assessment-only | No intervention | –The assessment-only group will participate in all pre- and post-intervention assessments, but will not receive the Listening Project Protocol. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children must be between ages 6-17 years
- children must be able to read/speak in English. Parents must be able to read/speak in either English or Spanish
- children must be patients, students and/or residents at Reiss-Davis/Vista del Mar
Key exclusion criteria (4 listed)
- children who wear a hearing device
- children with a history of heart disease
- children who are currently being treated for a seizure disorder
- children who are non-verbal
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 |
|---|---|---|
| Listening Project ProtocolThe filtered-music intervention will consist of listening to computer-altered acoustic stimulation, designed to modulate the frequency band of vocal music passed to the participant. The frequency characteristics of the acoustic stimulation are selected to emphasize the relative importance of specific frequencies in conveying the information embedded in human speech. Modulation of the acoustic energy within the frequencies of human voice, similar to an exaggerated vocal prosody, are hypothesized to recruit and modulate the neural regulation of the middle ear muscles and to functionally reduce sound hypersensitivities and improve auditory processing. The non-filtered music intervention will consist of the same music as the filtered-music intervention. | Behavioural | Filtered Music Intervention, Nonfiltered Music Intervention |
Primary outcome
Change from baseline in auditory hypersensitivity at 1 week, and at 2 months
Time frame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 2 months post-intervention
Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)
4 secondary outcomes
Change from baseline in state regulation at 1 week, and at 2 months
Time frame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention
Change from baseline in auditory processing at 1 week, and at 2 months
Time frame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention
Change from baseline in social behavior at 1 week, and at 2 months
Time frame: post-intervention (within 1 week after the intervention), 2 months post-intervention
Change from baseline in middle ear transfer function at 1 week, and at 2 months
Time frame: post-intervention (within 1 week after the intervention), 2 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
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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.
Keri J Heilman, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Listening Project Protocol in people with Auditory Perceptual Disorders and Stress Disorder, run by University of North Carolina, Chapel Hill 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 3 inclusion and 4 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 25 Aug 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 baseline in auditory hypersensitivity at 1 week, and at 2 months (time frame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 2 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2021.