Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-27 @ 1:29 AM
Study NCT ID:
NCT04962750
Status:
COMPLETED
Last Update Posted:
2021-07-15
First Post:
2021-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Level Laser Therapy for Treatment of Tinnitus in Red Sea Scuba Divers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014012', 'term': 'Tinnitus'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-03', 'studyFirstSubmitDate': '2021-07-03', 'studyFirstSubmitQcDate': '2021-07-03', 'lastUpdatePostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tinnitus Questionnaire score', 'timeFrame': '20 days', 'description': 'A score that evaluates level of tinnitus'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tinnitus']}, 'descriptionModule': {'briefSummary': 'Scuba Diving has become a popular hobby, for a leisure activity, diving puts the auditory system at the risk of a wide variety of complaints including tinnitus, Low level laser therapy is a new modality in treatment of tinnitus. This study evaluates effect of laser therapy on tinnitus of Scuba divers in Red Sea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- scuba divers\n\nExclusion Criteria:\n\n* Other ear or neurological diseases'}, 'identificationModule': {'nctId': 'NCT04962750', 'briefTitle': 'Low Level Laser Therapy for Treatment of Tinnitus in Red Sea Scuba Divers', 'organization': {'class': 'NETWORK', 'fullName': 'Egyptian Biomedical Research Network'}, 'officialTitle': 'Low Level Laser Therapy for Treatment of Tinnitus in Red Sea Scuba Divers: A Randomized Clinical Study', 'orgStudyIdInfo': {'id': 'N13476'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'laser therapy', 'interventionNames': ['Device: Low level laser therapy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'interventionNames': ['Other: Sham device']}], 'interventions': [{'name': 'Low level laser therapy', 'type': 'DEVICE', 'description': 'Low level laser therapy from suitable machine', 'armGroupLabels': ['laser therapy']}, {'name': 'Sham device', 'type': 'OTHER', 'description': "The device wasn't working", 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Osama El-sayyad', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Benha University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Egyptian Biomedical Research Network', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}