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The Listening Project: Tuning Into Change

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ClinicalTrials.gov Identifier: NCT02064257
Recruitment Status : Completed
First Posted : February 17, 2014
Last Update Posted : October 7, 2019
Sponsor:
Collaborator:
Australian Childhood Foundation
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE February 10, 2014
First Posted Date  ICMJE February 17, 2014
Last Update Posted Date October 7, 2019
Actual Study Start Date  ICMJE October 2014
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2014)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2015)
  • 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
  • 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
  • social behavior [ Time Frame: post-intervention (within 1 week after the intervention), 1 month post-intervention ]
    Listening Project Parent Questionnaire
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2014)
  • 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
  • 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
  • social behavior [ Time Frame: post-intervention (within 1 week after the intervention), 1 month post-intervention ]
    Listening Project Parent Questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Listening Project: Tuning Into Change
Official Title  ICMJE The Listening Project: Tuning Into Change
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Auditory Perceptual Disorders
  • Stress Disorder
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Listening Project Protocol
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 3, 2019)
43
Original Estimated Enrollment  ICMJE
 (submitted: February 13, 2014)
60
Actual Study Completion Date  ICMJE September 2019
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02064257
Other Study ID Numbers  ICMJE 13-2304
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE Australian Childhood Foundation
Investigators  ICMJE
Principal Investigator: Keri J Heilman, PhD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP