The Listening Project: Tuning Into Change

N/ACompletedNCT02064257

University of North Carolina, Chapel Hill43 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Auditory Perceptual Disorders Stress Disorder

Interventions

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.

Eligibility

Sex: ALLMin age: 7 YearsMax age: 14 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Auditory hypersensitivity

Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)

Time frame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention

Secondary Outcomes

Autonomic state regulation

heart rate, heart period, high-frequency heart rate variability/respiratory sinus arrhythmia

Time frame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention

Auditory processing

filtered words, competing words subscales of SCAN

Time frame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention

social behavior

Listening Project Parent Questionnaire

Time frame: post-intervention (within 1 week after the intervention), 1 month post-intervention

Middle ear muscle transfer function

MESAS (Middle Ear Sound Absorption System)

Time frame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention

The Listening Project: Tuning Into Change

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes