The Listening Project: Tuning Into Change

Stress Disorder Clinical Trial

Official title:

The Listening Project: Tuning Into Change

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02064257
• Other study ID #: 13-2304
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: September 2019

Study information

• Verified date: August 2021
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Auditory Perceptual Disorders
• Disease
• Perceptual Disorders
• Stress Disorder

Intervention

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.

Locations

Country	Name	City	State
Australia	Child Trauma Service Unit, Australian Childhood Foundation	Ringwood	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Australian Childhood Foundation

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Auditory hypersensitivity	Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)	pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention
Secondary	Autonomic state regulation	heart rate, heart period, high-frequency heart rate variability/respiratory sinus arrhythmia	pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention
Secondary	Auditory processing	filtered words, competing words subscales of SCAN	pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention
Secondary	social behavior	Listening Project Parent Questionnaire	post-intervention (within 1 week after the intervention), 1 month post-intervention
Secondary	Middle ear muscle transfer function	MESAS (Middle Ear Sound Absorption System)	pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention