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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02064257




Registration number
NCT02064257
Ethics application status
Date submitted
10/02/2014
Date registered
17/02/2014
Date last updated
25/08/2021

Titles & IDs
Public title
The Listening Project: Tuning Into Change
Scientific title
The Listening Project: Tuning Into Change
Secondary ID [1] 0 0
13-2304
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Auditory Perceptual Disorders 0 0
Stress Disorder 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Listening Project Protocol

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.

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.


Behaviour: 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 code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Auditory hypersensitivity
Timepoint [1] 0 0
pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention
Secondary outcome [1] 0 0
Autonomic state regulation
Timepoint [1] 0 0
pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention
Secondary outcome [2] 0 0
Auditory processing
Timepoint [2] 0 0
pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention
Secondary outcome [3] 0 0
social behavior
Timepoint [3] 0 0
post-intervention (within 1 week after the intervention), 1 month post-intervention
Secondary outcome [4] 0 0
Middle ear muscle transfer function
Timepoint [4] 0 0
pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention

Eligibility
Key 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
Minimum age
7 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Children who wear a hearing-device

- Children with a history of heart disease

- Children who are currently being treated for seizure disorder

Study design
Purpose of the study
Basic Science
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2019
Sample size
Target
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Child Trauma Service Unit, Australian Childhood Foundation - Ringwood
Recruitment postcode(s) [1] 0 0
3134 - Ringwood

Funding & Sponsors
Primary sponsor type
Other
Name
University of North Carolina, Chapel Hill
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian Childhood Foundation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02064257
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Keri J Heilman, PhD
Address 0 0
University of North Carolina, Chapel Hill
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02064257