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

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).

Study Overview

• Status: Completed
• Conditions: Stress Disorder; Auditory Perceptual Disorders
• Intervention / Treatment: Behavioral: Listening Project Protocol

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Keri J Heilman, PhD; Phone Number: 919-843-2220; Email: keri_heilman@med.unc.edu
• Study Contact Backup: Name: Lynda Thompson, PhD; Phone Number: 905 803-8066; Email: lyndathom@gmail.com

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada
      • ADD Centre and Biofeedback Institute of Toronto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 53 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: ADD Centre© and Biofeedback Institute of Toronto©
• Investigators: Principal Investigator: Keri J Heilman, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): November 17, 2023
• Study Completion (Actual): November 17, 2023

Study Registration Dates

• First Submitted: February 8, 2016
• First Submitted That Met QC Criteria: February 8, 2016
• First Posted (Estimated): February 11, 2016

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Autonomic nervous system; Social behavior; Auditory processing disorder
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Otorhinolaryngologic Diseases; Ear Diseases; Cognition Disorders; Retrocochlear Diseases; Auditory Diseases, Central; Perceptual Disorders; Auditory Perceptual Disorders
• Other Study ID Numbers: 15-1954

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No