Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-02-22 @ 4:14 AM
Study NCT ID:
NCT06021795
Status:
COMPLETED
Last Update Posted:
2025-01-01
First Post:
2023-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sounds for Sleep Study in Patients Suffering From Moderate to Severe Insomnia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-31', 'studyFirstSubmitDate': '2023-08-27', 'studyFirstSubmitQcDate': '2023-08-27', 'lastUpdatePostDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Insomnia Severity Index (ISI)', 'timeFrame': '4 weeks', 'description': 'Reduction in Insomnia Severity'}], 'secondaryOutcomes': [{'measure': 'Change in Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '4 weeks', 'description': 'Reduction in Sleep Quality'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Insomnia']}, 'descriptionModule': {'briefSummary': 'Assess the effect of a customized audio track delivered via standard commercially-available bone conduction headsets on the quality of sleep', 'detailedDescription': 'A single-center study in 25 subjects suffering from moderate to severe insomnia and assess the effectiveness of the intervention. Intervention consists of treatment using a customized audio track delivered via standard commercially-available bone conduction headsets daily for four (4) weeks. Effectiveness is defined by a statistically significant improvement in Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) at baseline versus the end of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age and older\n* Meets DSM 5 criteria for insomnia disorder\n* Insomnia Severity Index (ISI) of 15 - 28\n\nExclusion Criteria:\n\n* Use of sleep medications, sedating or alerting medications or antidepressants in the last 3 months\n* Diagnosis of any autoimmune disorder or any medical or sleep disorder that could affect sleep\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT06021795', 'briefTitle': 'Sounds for Sleep Study in Patients Suffering From Moderate to Severe Insomnia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Third Wave Therapeutics'}, 'officialTitle': 'Sounds for Sleep Study in Patients Suffering From Moderate to Severe Insomnia', 'orgStudyIdInfo': {'id': 'CP-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Treatment using a customized sound audio track delivered via standard commercially available bone conduction headsets', 'interventionNames': ['Device: Sound Treatment']}], 'interventions': [{'name': 'Sound Treatment', 'type': 'DEVICE', 'description': 'Customized sound audio track delivered via standard commercially available bone conduction headset', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94108', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco Otolaryngology Medical Group', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Elan Hekier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Francisco Otolaryngology Medical Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Third Wave Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}