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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02680730
Recruitment Status : Recruiting
First Posted : February 11, 2016
Last Update Posted : November 21, 2022
Sponsor:
Collaborator:
ADD Centre© and Biofeedback Institute of Toronto©
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
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Brief 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. 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).


Condition or disease Intervention/treatment Phase
Auditory Perceptual Disorders Stress Disorder Behavioral: Listening Project Protocol Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Listening Project at the ADD Centre and Biofeedback Institute of Toronto
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention only
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
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.
Experimental: Intervention + Stability
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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 ]
    heart rate, heart period, high-frequency heart rate variability/respiratory sinus arrhythmia

  2. 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 ]
    filtered words, competing words subscales of SCAN-3:C Tests for Auditory Processing Processing Disorders in Children

  3. 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 ]
    Listening Project Parent Questionnaire

  4. 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 ]
    Middle Ear Sound Absorption System (MESAS)

  5. 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 ]
    Prosody assessment of recorded speech

  6. 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 ]
    Connors Questionnaire

  7. 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 ]
    Integrated Visual and Auditory Continuous Performance Task ("IVA")


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Individuals must be between ages 7-55 years
  2. Individuals must be fluent (read and write) in English. Parents must be able to read/speak in English.
  3. Individuals must be current or past clients at the ADD Centres Limited & Biofeedback Institute of Toronto

Exclusion criteria:

  1. Individuals who wear a hearing-device
  2. Individuals with a history of heart disease
  3. Individuals who are currently being treated for seizure disorder
  4. Individuals who are non-verbal
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02680730


Contacts
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Contact: Keri J Heilman, PhD 919-843-2220 keri_heilman@med.unc.edu
Contact: Lynda Thompson, PhD 905 803-8066 lyndathom@gmail.com

Locations
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Canada, Ontario
ADD Centre and Biofeedback Institute of Toronto Recruiting
Mississauga, Ontario, Canada
Contact: Lynda Thompson, PhD    905 803-8066    lyndathom@gmail.com   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
ADD Centre© and Biofeedback Institute of Toronto©
Investigators
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Principal Investigator: Keri J Heilman, PhD University of North Carolina, Chapel Hill
More Information
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02680730    
Other Study ID Numbers: 15-1954
First Posted: February 11, 2016    Key Record Dates
Last Update Posted: November 21, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
Autonomic nervous system
Auditory processing disorder
Social behavior
Additional relevant MeSH terms:
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Auditory Perceptual Disorders
Perceptual Disorders
Disease
Pathologic Processes
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
 Auditory Diseases, Central
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Brain Diseases
Central Nervous System Diseases
Cognition Disorders
Neurocognitive Disorders