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

Primary Purpose

Auditory Perceptual Disorders, Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Listening Project Protocol
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Auditory Perceptual Disorders focused on measuring Autonomic nervous system, Auditory processing disorder, Social behavior

Eligibility Criteria

7 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ADD Centre and Biofeedback Institute of TorontoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention only

Intervention + Stability

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in auditory hypersensitivity at 1 week, and at 1 month
Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)

Secondary Outcome Measures

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
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
Change from baseline in social behavior at 1 week, and at 1 month
Listening Project Parent Questionnaire
Change from baseline in middle ear transfer function at 1 week, and at 1 month
Middle Ear Sound Absorption System (MESAS)
Change from baseline in prosody at 1 week, and at 2 months
Prosody assessment of recorded speech
Change from baseline in attention at 1 week, and at 2 months
Connors Questionnaire
Change from baseline in attention (task) at 1 week, and at 2 months
Integrated Visual and Auditory Continuous Performance Task ("IVA")

Full Information

First Posted
February 8, 2016
Last Updated
June 12, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
ADD Centre© and Biofeedback Institute of Toronto©
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1. Study Identification

Unique Protocol Identification Number
NCT02680730
Brief Title
The Listening Project at the ADD Centre and Biofeedback Institute of Toronto
Official Title
The Listening Project at the ADD Centre and Biofeedback Institute of Toronto
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
ADD Centre© and Biofeedback Institute of Toronto©

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Auditory Perceptual Disorders, Stress Disorder
Keywords
Autonomic nervous system, Auditory processing disorder, Social behavior

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention only
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention + Stability
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Listening Project Protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in auditory hypersensitivity at 1 week, and at 1 month
Description
Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)
Time Frame
pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention
Secondary Outcome Measure Information:
Title
Change from baseline in state regulation at 1 week, and at 1 month
Description
heart rate, heart period, high-frequency heart rate variability/respiratory sinus arrhythmia
Time Frame
pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention
Title
Change from baseline in auditory processing at 1 week, and at 1 month
Description
filtered words, competing words subscales of SCAN-3:C Tests for Auditory Processing Processing Disorders in Children
Time Frame
pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention
Title
Change from baseline in social behavior at 1 week, and at 1 month
Description
Listening Project Parent Questionnaire
Time Frame
post-intervention (within 1 week after the intervention), 1 month post-intervention
Title
Change from baseline in middle ear transfer function at 1 week, and at 1 month
Description
Middle Ear Sound Absorption System (MESAS)
Time Frame
pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention
Title
Change from baseline in prosody at 1 week, and at 2 months
Description
Prosody assessment of recorded speech
Time Frame
pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention
Title
Change from baseline in attention at 1 week, and at 2 months
Description
Connors Questionnaire
Time Frame
pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention
Title
Change from baseline in attention (task) at 1 week, and at 2 months
Description
Integrated Visual and Auditory Continuous Performance Task ("IVA")
Time Frame
pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keri J Heilman, PhD
Phone
919-843-2220
Email
keri_heilman@med.unc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lynda Thompson, PhD
Phone
905 803-8066
Email
lyndathom@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keri J Heilman, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
ADD Centre and Biofeedback Institute of Toronto
City
Mississauga
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynda Thompson, PhD
Phone
905 803-8066
Email
lyndathom@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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