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

NCT ID: NCT02680730

Last Updated: 2024-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2023-11-17

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).

Conditions

Auditory Perceptual Disorders; Stress Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Listening Project Protocol

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Listening Project Protocol

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ADD Centre© and Biofeedback Institute of Toronto©

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keri J Heilman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

ADD Centre and Biofeedback Institute of Toronto

Mississauga, Ontario, Canada

Countries

Canada

Other Identifiers

15-1954

Identifier Type: -

Identifier Source: org_study_id