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

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Recruiting
CT.gov ID
NCT02680730
Collaborator
ADD Centre© and Biofeedback Institute of Toronto© (Other)
30
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2
51
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Study Details

Study Description

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
  • Behavioral: Listening Project Protocol
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Sep 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. Change from baseline in auditory hypersensitivity at 1 week, and at 1 month [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 [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 [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 [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 [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 [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 [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 [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

Criteria

Ages Eligible for Study:
7 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 ADD Centre and Biofeedback Institute of Toronto Mississauga Ontario Canada

Sponsors and Collaborators

  • University of North Carolina, Chapel Hill
  • ADD Centre© and Biofeedback Institute of Toronto©

Investigators

  • Principal Investigator: Keri J Heilman, PhD, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT02680730
Other Study ID Numbers:
  • 15-1954
First Posted:
Feb 11, 2016
Last Update Posted:
Apr 14, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 14, 2022