Clinical Trial: The Listening Project: Tuning Into Change
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 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 Summary:
Sponsor: Stephen Porges, PhD
Current Primary Outcome: Auditory hypersensitivity [ Time Frame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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:
- 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
Information By: University of North Carolina, Chapel Hill
Dates:
Date Received: February 10, 2014
Date Started: October 2014
Date Completion: April 2017
Last Updated: May 4, 2016
Last Verified: May 2016