Auditory Perceptual DisordersNCT02680730
The Listening Project at the ADD Centre and Biofeedback Institute of Toronto
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 Canada.
Trial summary
Purpose: A research project will be conducted at the ADD ("Attention Deficit Disorder") Centre and Biofeedback Institute of Toronto to evaluate the feasibility of the Listening Project Protocol (LPP) intervention in individuals with difficulties with autonomic and/or behavioral regulation. Read more about this study
- Who is it for?
- Ages 7 to 55 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
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2018to 17 Nov 2023
- 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 7 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Individuals must be between ages 7-55 years
- Individuals must be fluent (read and write) in English. Parents must be able to read/speak in English.
- Individuals must be current or past clients at the ADD Centres Limited \& Biofeedback Institute of Toronto
Who cannot join
- Individuals who wear a hearing-device
- Individuals with a history of heart disease
- Individuals who are currently being treated for seizure disorder
- Individuals who are non-verbal
Trial locations and contacts
1 site in 1 country.
Canada1 site
ADD Centre and Biofeedback Institute of Toronto
Mississauga, Ontario
About this study
Purpose: A research project will be conducted at the ADD ("Attention Deficit Disorder") Centre and Biofeedback Institute of Toronto to evaluate the feasibility of the Listening Project Protocol (LPP) intervention in individuals with difficulties with autonomic and/or behavioral regulation. The LPP is designed as a "neural exercise" to reduce auditory hypersensitivities, to improve auditory processing of speech, and to improve behavioral state regulation. These improvements should translate into increase feelings of safety and calmness, thereby promoting improvement in social behavior.
Participants: 30 participants, males and females between ages 7-55 years, will be recruited for the study. Participants will be patients at the ADD Centre and Biofeedback Institute of Toronto.
Procedures: Participants will be divided into 1 of 2 groups (1:1 ratio). Both groups will have a pre-intervention assessment #2, intervention, 1 week post intervention assessment and 1 month post intervention assessment. Group 2 will have an additional pre-intervention assessment session #1 (1 week previous to pre-intervention assessment #2) to assess the stability of the measures prior to starting the intervention. Pre-, post-, and 1 month followup assessment will include parent and/or self-report questionnaires, and measures of the individual's auditory processing ("SCAN"), affect recognition ("DARE" Dynamic Affect Recognition Evaluation), heart rate, prosody, "RSA" respiratory sinus arrhythmia (derived from non-invasive ECG recording), and middle ear transfer function ("MESAS" - Middle Ear Sound Absorption System).
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention only | Experimental | Participants will be included in 1 pre-intervention and 2 post-assessment measures. Participants will receive the Listening Project Protocol intervention (filtered music). The duration of the intervention is approximately 60 minutes per day, for 5 consecutive days. Receives: Behavioral: Listening Project Protocol |
| Intervention + Stability | Experimental | Participants will be included in 2 pre-intervention and 2 post-assessment measures. The additional pre-intervention assessment will allow for assessment of stability of measures. Participants will receive the Listening Project Protocol intervention (filtered music). The duration of the intervention is approximately 60 minutes per day, for 5 consecutive days. Receives: Behavioral: 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 1 month
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), 1 month post-intervention
Secondary outcomes (7)
Change from baseline in state regulation at 1 week, and at 1 month
heart rate, heart period, high-frequency heart rate variability/respiratory sinus arrhythmia
Measured: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention
Change from baseline in auditory processing at 1 week, and at 1 month
filtered words, competing words subscales of SCAN-3:C Tests for Auditory Processing Processing Disorders in Children
Measured: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention
Change from baseline in social behavior at 1 week, and at 1 month
Listening Project Parent Questionnaire
Measured: post-intervention (within 1 week after the intervention), 1 month post-intervention
Change from baseline in middle ear transfer function at 1 week, and at 1 month
Middle Ear Sound Absorption System (MESAS)
Measured: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention
Change from baseline in prosody at 1 week, and at 2 months
Prosody assessment of recorded speech
Measured: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention
Change from baseline in attention at 1 week, and at 2 months
Connors Questionnaire
Measured: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention
Change from baseline in attention (task) at 1 week, and at 2 months
Integrated Visual and Auditory Continuous Performance Task ("IVA")
Measured: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study start1 Sep 2018
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
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
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- ADD Centre© and Biofeedback Institute of Toronto©
- Responsible party
- Sponsor
- Investigators
- Keri J Heilman, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680730
- Sponsor's protocol ID
- 15-1954
- Status last verified
- Mar 2024
- First submitted
- 8 Feb 2016
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Listening Project at the ADD Centre and Biofeedback Institute of Toronto
- ClinicalTrials.gov ID
- NCT02680730
- Acronym / sponsor ID
- 15-1954
- Conditions
- Auditory Perceptual Disorders, Stress Disorder
- Keywords
- Autonomic nervous system, Auditory processing disorder, Social behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- ADD Centre© and Biofeedback Institute of Toronto©
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 11 Feb 2016 (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.
Purpose: A research project will be conducted at the ADD ("Attention Deficit Disorder") Centre and Biofeedback Institute of Toronto to evaluate the feasibility of the Listening Project Protocol (LPP) intervention in individuals with difficulties with autonomic and/or behavioral regulation. The LPP is designed as a "neural exercise" to reduce auditory hypersensitivities, to improve auditory processing of speech, and to improve behavioral state regulation. These improvements should translate into increase feelings of safety and calmness, thereby promoting improvement in social behavior.
Participants: 30 participants, males and females between ages 7-55 years, will be recruited for the study. Participants will be patients at the ADD Centre and Biofeedback Institute of Toronto.
Procedures: Participants will be divided into 1 of 2 groups (1:1 ratio). Both groups will have a pre-intervention assessment #2, intervention, 1 week post intervention assessment and 1 month post intervention assessment. Group 2 will have an additional pre-intervention assessment session #1 (1 week previous to pre-intervention assessment #2) to assess the stability of the measures prior to starting the intervention. Pre-, post-, and 1 month followup assessment will include parent and/or self-report questionnaires, and measures of the individual's auditory processing ("SCAN"), affect recognition ("DARE" Dynamic Affect Recognition Evaluation), heart rate, prosody, "RSA" respiratory sinus arrhythmia (derived from non-invasive ECG recording), and middle ear transfer function ("MESAS" - Middle Ear Sound Absorption System).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention only | Experimental | Behavioral: Listening Project ProtocolParticipants will be included in 1 pre-intervention and 2 post-assessment measures. Participants will receive the Listening Project Protocol intervention (filtered music). The duration of the intervention is approximately 60 minutes per day, for 5 consecutive days. |
| Intervention + Stability | Experimental | Behavioral: Listening Project ProtocolParticipants will be included in 2 pre-intervention and 2 post-assessment measures. The additional pre-intervention assessment will allow for assessment of stability of measures. Participants will receive the Listening Project Protocol intervention (filtered music). The duration of the intervention is approximately 60 minutes per day, for 5 consecutive days. |
Who may qualify
- Ages
- 7 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Individuals must be between ages 7-55 years
- Individuals must be fluent (read and write) in English. Parents must be able to read/speak in English.
- Individuals must be current or past clients at the ADD Centres Limited \& Biofeedback Institute of Toronto
Key exclusion criteria (4 listed)
- Individuals who wear a hearing-device
- Individuals with a history of heart disease
- Individuals who are currently being treated for seizure disorder
- Individuals 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. | Behavioural | Intervention + Stability, Intervention only |
Primary outcome
Change from baseline in auditory hypersensitivity at 1 week, and at 1 month
Time frame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention
Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)
7 secondary outcomes
Change from baseline in state regulation at 1 week, and at 1 month
Time frame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention
Change from baseline in auditory processing at 1 week, and at 1 month
Time frame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention
Change from baseline in social behavior at 1 week, and at 1 month
Time frame: post-intervention (within 1 week after the intervention), 1 month post-intervention
Change from baseline in middle ear transfer function at 1 week, and at 1 month
Time frame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention
Change from baseline in prosody at 1 week, and at 2 months
Time frame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention
Change from baseline in attention at 1 week, and at 2 months
Time frame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention
Change from baseline in attention (task) at 1 week, and at 2 months
Time frame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month 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 29 Mar 2024.
- Individual participant dataSharing planned: No
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Neuronavigated rTMS for Treatment-Resistant Auditory Hallucinations
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fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations
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Not yet recruitingObservational study
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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 Canada.
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 29 Mar 2024. 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 Canada. 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 1 month (time frame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month 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 29 Mar 2024.