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

NCT02680730 | Completed

• 1 other identifier: 15-1954
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Auditory Perceptual Disorders; Stress Disorder

Keywords

Autonomic nervous system; Auditory processing disorder; Social behavior

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

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

  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

  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

  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

  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

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

Study Arms (2)

Intervention only

EXPERIMENTAL

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

Intervention + Stability

EXPERIMENTAL

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

Interventions

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.

Intervention + Stability; Intervention only

Eligibility Criteria

• Age: 7 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• ADD Centre© and Biofeedback Institute of Toronto©: collaborator

Study Sites (1)

ADD Centre and Biofeedback Institute of Toronto

Mississauga, Ontario, Canada

Location

MeSH Terms

Conditions

Auditory Perceptual Disorders; Stress Disorders, Traumatic; Social Behavior

Condition Hierarchy (Ancestors)

Auditory Diseases, Central; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Trauma and Stressor Related Disorders; Behavior

Study Officials

• Keri J Heilman, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: February 11, 2016
• Study Start: September 1, 2018
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)