Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT03552302
Status:
COMPLETED
Last Update Posted:
2021-08-30
First Post:
2017-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Yoga Exercise on Participates With Tinnitus
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': 'D015013', 'term': 'Yoga'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-27', 'studyFirstSubmitDate': '2017-02-07', 'studyFirstSubmitQcDate': '2018-05-29', 'lastUpdatePostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Assessment of the degree of tinnitus', 'timeFrame': '1. One week before yoga intervention. 2. Through study completion, an average of 12 week. 3. One month after the end of the study.', 'description': 'Chinese version of Tinnitus Handicap Inventory (THI). There were 25 questions and totally 100 points in THI. The answer for each questions is classified into three levels (will, sometimes, will not), and answering "will" gave 4 points, answering "sometimes" gave 2 points, and answering "will not " gave 0 points. The higher the total scores, the more severe the tinnitus.'}], 'secondaryOutcomes': [{'measure': 'Assessment of the degree of sleep quality.', 'timeFrame': '1. One week before yoga intervention. 2. Through study completion, an average of 12 week. 3. One month after the end of the study.', 'description': 'Chinese version of Pittsburgh Sleep Quality Index (PSQI). There were 18 counted items and totally 21 points. The answer for each questions is classified into four levels (frequent, sometimes, rare, never), and answering "frequent" gave 3 points, answering "sometimes" gave 2 points, answering "rare" gave 1 point, and answering "never" gave 0 point. The higher the total scores, the more severe the sleep problem.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Yoga', 'Tinnitus', 'Sleep'], 'conditions': ['Tinnitus']}, 'descriptionModule': {'briefSummary': 'This study aimed to investigate the effectiveness of Yoga on the tinnitus handicap and sleep quality in humans. We selected adult participates with chronic tinnitus (\\>6 months). All participates performed Yoga exercise once per week at outpatient department under the guidance of a professional teacher, and performed once daily by themselves at home for 12 weeks. Questionnaires of Tinnitus Handicap Inventory and Pittsburgh Sleep Quality Index were measured before the start of this study, at the end of this study, and 1 month after the end of this study.', 'detailedDescription': 'Tinnitus is the auditory phantom sensation in the absence of external sound stimulation. Tinnitus that persisted more than six months without improvement can be called chronic tinnitus. One report proposed the neurophysiological model of tinnitus. In addition, tinnitus patients suffered from insomnia, irritability, anxiety and/or depression.\n\nCurrent management of tinnitus is a drug-based treatment and/or nutritional supplementation. Music therapy, hearing aid therapy, and tinnitus retraining therapy (TRT), were also applied for patients with tinnitus. Even though, success rates of various tinnitus treatments were still unsatisfactory till now.\n\nThis study aimed to investigate the effectiveness of Yoga on the tinnitus handicap and sleep quality in humans. We selected adult participates with chronic tinnitus (\\>6 months). All participates performed Yoga exercise once per week at outpatient department under the guidance of a professional teacher, and performed once daily by themselves at home for 12 weeks. Questionnaires of Tinnitus Handicap Inventory and Pittsburgh Sleep Quality Index were measured before the start of this study, at the end of this study, and 1 month after the end of this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chronic Tinnitus participates.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participates with tinnitus persisted more than 6 months from ear, nose, and throat out-patient department.\n2. No drug treatment for their tinnitus in recent 3 months.\n3. No respiratory diseases (eg, asthma).\n4. Normal cognitive function.\n5. Normal language comprehension.\n\nExclusion Criteria:\n\n1. Pregnant females or menopausal females with hormone replacement therapy.\n2. Hypertension\n3. Glaucoma.\n4. Those who cannot express their opinions or follow orders.\n5. Cancer patients.\n6. Objective tinnitus.'}, 'identificationModule': {'nctId': 'NCT03552302', 'briefTitle': 'Effects of Yoga Exercise on Participates With Tinnitus', 'organization': {'class': 'OTHER', 'fullName': 'Dalin Tzu Chi General Hospital'}, 'officialTitle': 'Effects of Yoga Exercise on Tinnitus Handicap and Sleep Quality of the Participates With Tinnitus', 'orgStudyIdInfo': {'id': 'B10503015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Yoga exercise for 12 weeks', 'interventionNames': ['Behavioral: Yoga']}], 'interventions': [{'name': 'Yoga', 'type': 'BEHAVIORAL', 'description': '1. Yoga stretch warm-up exercise for 15 minutes.\n2. Five kinds of yoga correction method for 30 minutes (abdominal breathing, throat breathing, wind box breathing, nasal alternating breathing, buzzing breathing).\n3. Great rest for 15 minutes', 'armGroupLabels': ['Cases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66247', 'city': 'Chiayi City', 'country': 'Taiwan', 'facility': 'Dalin Tzu Chi General Hospital', 'geoPoint': {'lat': 23.47917, 'lon': 120.44889}}], 'overallOfficials': [{'name': 'Juen-Haur Hwang, Ph. D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Dalin Tzu Chi General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dalin Tzu Chi General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}