NCT02680730

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 7 Years – 55 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-09-01
• Primary completion: 2023-11-17
• Completion: 2023-11-17
• First posted: 2016-02-11
• Last updated: 2024-03-29

Locations

1 site across 1 country: Canada