The Listening Project: Tuning Into Change

NCT ID: NCT02064257

Last Updated: 2021-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2019-09-30

Brief Summary

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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

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Conditions

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Auditory Perceptual Disorders Stress Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Listening Project Protocol

Intervention Type BEHAVIORAL

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.

Assessment-only group

The assessment-only group will participate in all pre- and post-intervention assessments, but will not receive the Listening Project Protocol.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Australian Childhood Foundation

UNKNOWN

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Keri J Heilman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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Child Trauma Service Unit, Australian Childhood Foundation

Ringwood, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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13-2304

Identifier Type: -

Identifier Source: org_study_id

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