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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02680730
Enrollment
30
Registered
2016-02-11
Start date
2018-09-01
Completion date
2023-11-17
Last updated
2024-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Auditory Perceptual Disorders, Stress Disorder

Keywords

Autonomic nervous system, Auditory processing disorder, Social behavior

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).

Interventions

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.

Sponsors

ADD Centre© and Biofeedback Institute of Toronto©
CollaboratorOTHER
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in auditory hypersensitivity at 1 week, and at 1 monthpre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-interventionBrain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)

Secondary

MeasureTime frameDescription
Change from baseline in auditory processing at 1 week, and at 1 monthpre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-interventionfiltered 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 monthpost-intervention (within 1 week after the intervention), 1 month post-interventionListening Project Parent Questionnaire
Change from baseline in middle ear transfer function at 1 week, and at 1 monthpre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-interventionMiddle Ear Sound Absorption System (MESAS)
Change from baseline in state regulation at 1 week, and at 1 monthpre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-interventionheart rate, heart period, high-frequency heart rate variability/respiratory sinus arrhythmia
Change from baseline in attention at 1 week, and at 2 monthspre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-interventionConnors Questionnaire
Change from baseline in attention (task) at 1 week, and at 2 monthspre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-interventionIntegrated Visual and Auditory Continuous Performance Task (IVA)
Change from baseline in prosody at 1 week, and at 2 monthspre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-interventionProsody assessment of recorded speech

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026