ClinicalTrials.gov
ClinicalTrials.gov Menu

The Listening Project: Tuning Into Change

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02064257
Recruitment Status : Recruiting
First Posted : February 17, 2014
Last Update Posted : May 18, 2018
Sponsor:
Collaborator:
Australian Childhood Foundation
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Listening Project: Tuning Into Change
Study Start Date : October 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

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.



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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064257


Contacts
Contact: Joe Tucci, PhD 03 9874 3922 jtucci@childhood.org.au
Contact: Keri J Heilman, PhD keri_heilman@med.unc.edu

Locations
Australia, Victoria
Child Trauma Service Unit, Australian Childhood Foundation Recruiting
Ringwood, Victoria, Australia, 3134
Contact: Joe Tucci, PhD    03 9874 3922    jtucci@childhood.org.au   
Principal Investigator: Joe Tucci, PhD         
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

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02064257     History of Changes
Other Study ID Numbers: 13-2304
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

Keywords provided by University of North Carolina, Chapel Hill:
autonomic nervous system
auditory processing disorder
social behavior

Additional relevant MeSH terms:
Disease
Perceptual Disorders
Auditory Perceptual Disorders
Pathologic Processes
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Auditory Diseases, Central
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Brain Diseases
Central Nervous System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders