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NCT Number: NCT02064257

The Listening Project: Tuning Into Change

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.

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Key information

Conditions

Auditory Perceptual Disorders Auditory Diseases, Central Behavior Brain Diseases Central Nervous System Diseases Cognition Disorders Ear Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Perceptual Disorders Retrocochlear Diseases Signs and Symptoms Social Behavior Stress Disorder Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Child Trauma Service Unit, Australian Childhood Foundation

Ringwood, Victoria, 3134, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Listening Project Protocol

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.

Primary outcomes

  1. Auditory hypersensitivity

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

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

Secondary outcomes

  1. 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

  2. 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

  3. social behavior

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

    Listening Project Parent Questionnaire

  4. 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)

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Australian Childhood Foundation

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Feb 17, 2014
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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