The Listening Project at the ADD Centre and Biofeedback Institute of Toronto

Study Overview
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Brief Summary
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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).

Official Title
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The Listening Project at the ADD Centre and Biofeedback Institute of Toronto

Conditions
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Auditory Perceptual Disorders, Stress Disorder

Intervention / Treatment
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* Behavioral: Listening Project Protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion criteria: 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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention only<br>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. | Behavioral: Listening Project Protocol<br>* 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.<br>|
| Experimental: Intervention + Stability<br>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. | Behavioral: Listening Project Protocol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in auditory hypersensitivity at 1 week, and at 1 month | Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire) | pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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) | 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 | 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 | 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) | pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autonomic nervous system, Auditory processing disorder, Social behavior