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 : September 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Auditory Perceptual Disorders Stress Disorder||Behavioral: Listening Project Protocol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|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|
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.
- 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)
- 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)
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
|Child Trauma Service Unit, Australian Childhood Foundation|
|Ringwood, Victoria, Australia, 3134|
|Principal Investigator:||Keri J Heilman, PhD||University of North Carolina, Chapel Hill|