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

Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02680730
• Other study ID #: 15-1954
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: November 17, 2023

Study information

• Verified date: March 2024
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 17, 2023
• Est. primary completion date: November 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Auditory Perceptual Disorders
• Perceptual Disorders
• Stress Disorder

Intervention

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.

Locations

Country	Name	City	State
Canada	ADD Centre and Biofeedback Institute of Toronto	Mississauga	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	ADD Centre© and Biofeedback Institute of Toronto©

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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