Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2026-02-13 @ 2:34 AM
Study NCT ID:
NCT02064257
Status:
COMPLETED
Last Update Posted:
2021-08-25
First Post:
2014-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Listening Project: Tuning Into Change
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001308', 'term': 'Auditory Perceptual Disorders'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D012919', 'term': 'Social Behavior'}], 'ancestors': [{'id': 'D001304', 'term': 'Auditory Diseases, Central'}, {'id': 'D012181', 'term': 'Retrocochlear Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-24', 'studyFirstSubmitDate': '2014-02-10', 'studyFirstSubmitQcDate': '2014-02-13', 'lastUpdatePostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Auditory hypersensitivity', 'timeFrame': 'pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention', 'description': 'Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)'}], 'secondaryOutcomes': [{'measure': 'Autonomic state regulation', 'timeFrame': 'pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention', 'description': 'heart rate, heart period, high-frequency heart rate variability/respiratory sinus arrhythmia'}, {'measure': 'Auditory processing', 'timeFrame': 'pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention', 'description': 'filtered words, competing words subscales of SCAN'}, {'measure': 'social behavior', 'timeFrame': 'post-intervention (within 1 week after the intervention), 1 month post-intervention', 'description': 'Listening Project Parent Questionnaire'}, {'measure': 'Middle ear muscle transfer function', 'timeFrame': 'pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention', 'description': 'MESAS (Middle Ear Sound Absorption System)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['autonomic nervous system', 'auditory processing disorder', 'social behavior'], 'conditions': ['Auditory Perceptual Disorders', 'Stress Disorder']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children must be between ages 7-14 years\n* Children and parent providing permission must be able to read/speak in English\n* Children must be receiving services from the Child Trauma Service unit of the Australian Childhood Foundation\n\nExclusion Criteria:\n\n* Children who wear a hearing-device\n* Children with a history of heart disease\n* Children who are currently being treated for seizure disorder'}, 'identificationModule': {'nctId': 'NCT02064257', 'briefTitle': 'The Listening Project: Tuning Into Change', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'The Listening Project: Tuning Into Change', 'orgStudyIdInfo': {'id': '13-2304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': '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.', 'interventionNames': ['Behavioral: Listening Project Protocol']}, {'type': 'NO_INTERVENTION', 'label': 'Assessment-only group', 'description': 'The assessment-only group will participate in all pre- and post-intervention assessments, but will not receive the Listening Project Protocol.'}], 'interventions': [{'name': 'Listening Project Protocol', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3134', 'city': 'Ringwood', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Child Trauma Service Unit, Australian Childhood Foundation', 'geoPoint': {'lat': -37.81667, 'lon': 145.23333}}], 'overallOfficials': [{'name': 'Keri J Heilman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Australian Childhood Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}