The Listening Project: Tuning Into Change

• ClinicalTrials.gov Identifier: NCT02064257
• Recruitment Status: Completed
• First Posted: February 17, 2014
• Last Update Posted: August 25, 2021
• Sponsor: University of North Carolina, Chapel Hill
• Collaborator: Australian Childhood Foundation
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

Study Description

Brief Summary:

A research project funded by the Australian Childhood Foundation (ACF) will be conducted in Australian facilities of the ACF to evaluate the effectiveness of the Listening Project Protocol (LPP) in children with a trauma history. The LPP is designed as a "neural exercise" to reduce auditory hypersensitivities, to improve auditory processing of speech, and to improve behavioral state regulation. The LPP uses acoustic stimulation to exercise the neural regulation of the middle ear structures to rehabilitate and to normalize the acoustic transfer function of the middle ear structures. The current study is being conducted to evaluate efficacy and feasibility of the LPP and will use objective measures to evaluate changes in acoustic transfer function of the middle ears structures, auditory processing skills, physiological state regulation, and sensory symptoms.

Condition or disease	Intervention/treatment	Phase
Auditory Perceptual Disorders; Stress Disorder	Behavioral: Listening Project Protocol	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 43 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: The Listening Project: Tuning Into Change
• Actual Study Start Date: October 2014
• Actual Primary Completion Date: September 2019
• Actual Study Completion Date: September 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention group; Participants will be included in all pre-intervention and post-assessment measures. Participants will receive the Listening Project Protocol intervention. The duration of the intervention is approximately 45 minutes per day, for 5 consecutive days.	Behavioral: Listening Project Protocol; The 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.
No Intervention: Assessment-only group; The assessment-only group will participate in all pre- and post-intervention assessments, but will not receive the Listening Project Protocol.

Outcome Measures

Primary Outcome Measures :

1. Auditory hypersensitivity [ 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 Outcome Measures :

1. Autonomic state regulation [ Time Frame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention ]
   heart rate, heart period, high-frequency heart rate variability/respiratory sinus arrhythmia
2. Auditory processing [ Time Frame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention ]
   filtered words, competing words subscales of SCAN
3. social behavior [ Time Frame: post-intervention (within 1 week after the intervention), 1 month post-intervention ]
   Listening Project Parent Questionnaire
4. Middle ear muscle transfer function [ Time Frame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention ]
   MESAS (Middle Ear Sound Absorption System)

Eligibility Criteria

• Ages Eligible for Study: 7 Years to 14 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Children must be between ages 7-14 years
• Children and parent providing permission must be able to read/speak in English
• Children must be receiving services from the Child Trauma Service unit of the Australian Childhood Foundation

Exclusion Criteria:

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

Contacts and Locations

Locations

Australia, Victoria

Child Trauma Service Unit, Australian Childhood Foundation

Ringwood, Victoria, Australia, 3134

Sponsors and Collaborators

University of North Carolina, Chapel Hill

Australian Childhood Foundation

Investigators

• Principal Investigator: Keri J Heilman, PhD; University of North Carolina, Chapel Hill

More Information

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT02064257
• Other Study ID Numbers: 13-2304
• First Posted: February 17, 2014
• Last Update Posted: August 25, 2021
• Last Verified: August 2021

Keywords provided by University of North Carolina, Chapel Hill:

autonomic nervous system; auditory processing disorder; social behavior

Additional relevant MeSH terms:

Auditory Perceptual Disorders; Perceptual Disorders; Disease; Pathologic Processes; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Auditory Diseases, Central; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Brain Diseases; Central Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders