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Completed

NCT Number: NCT02680730

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).

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals must be between ages 7-55 years
  • Individuals must be fluent (read and write) in English. Parents must be able to read/speak in English.
  • Individuals must be current or past clients at the ADD Centres Limited & Biofeedback Institute of Toronto

Exclusion criteria

  • Individuals who wear a hearing-device
  • Individuals with a history of heart disease
  • Individuals who are currently being treated for seizure disorder
  • Individuals who are non-verbal

Treatment and study plan

Listening Project Protocol

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.

Primary outcomes

  1. Change from baseline in auditory hypersensitivity at 1 week, and at 1 month

    Time frame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention

    Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)

Secondary outcomes

  1. Change from baseline in state regulation at 1 week, and at 1 month

    Time frame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention

    heart rate, heart period, high-frequency heart rate variability/respiratory sinus arrhythmia

  2. Change from baseline in auditory processing at 1 week, and at 1 month

    Time frame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention

    filtered words, competing words subscales of SCAN-3:C Tests for Auditory Processing Processing Disorders in Children

  3. Change from baseline in social behavior at 1 week, and at 1 month

    Time frame: post-intervention (within 1 week after the intervention), 1 month post-intervention

    Listening Project Parent Questionnaire

  4. Change from baseline in middle ear transfer function at 1 week, and at 1 month

    Time frame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention

    Middle Ear Sound Absorption System (MESAS)

  5. Change from baseline in prosody at 1 week, and at 2 months

    Time frame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention

    Prosody assessment of recorded speech

  6. Change from baseline in attention at 1 week, and at 2 months

    Time frame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention

    Connors Questionnaire

  7. Change from baseline in attention (task) at 1 week, and at 2 months

    Time frame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention

    Integrated Visual and Auditory Continuous Performance Task ("IVA")

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • ADD Centre© and Biofeedback Institute of Toronto©

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Feb 11, 2016
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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