Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2026-02-09 @ 9:12 AM
Study NCT ID:
NCT04026932
Status:
UNKNOWN
Last Update Posted:
2019-07-19
First Post:
2019-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical Effects of Modified TRS Treatment
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-18', 'studyFirstSubmitDate': '2019-07-11', 'studyFirstSubmitQcDate': '2019-07-18', 'lastUpdatePostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tinnitus Handicapped Inventory (THI)', 'timeFrame': '1 months from baseline', 'description': 'THI is a self-assessment inventory including 25 items with grades four categories of tinnitus severity: slight corresponding to a score 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus.'}, {'measure': 'Tinnitus Handicapped Inventory (THI)', 'timeFrame': '3 months from baseline', 'description': 'THI is a self-assessment inventory including 25 items with grades four categories of tinnitus severity: slight corresponding to a score 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus.'}, {'measure': 'Tinnitus Handicapped Inventory (THI)', 'timeFrame': '9 months from baseline', 'description': 'THI is a self-assessment inventory including 25 items with grades four categories of tinnitus severity: slight corresponding to a score 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus.'}, {'measure': 'Tinnitus Handicapped Inventory (THI)', 'timeFrame': '12 months from baseline', 'description': 'THI is a self-assessment inventory including 25 items with grades four categories of tinnitus severity: slight corresponding to a score 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus.'}, {'measure': 'Hospital Anxiety and Distress Scale (HADS)', 'timeFrame': '1 months from baseline', 'description': 'HADS includes two subscales for anxiety and depression, each with respective 7 items, and the grades are valued by scoring: negative (0-7), positive (8-21).'}, {'measure': 'Hospital Anxiety and Distress Scale (HADS)', 'timeFrame': '3 months from baseline', 'description': 'HADS includes two subscales for anxiety and depression, each with respective 7 items, and the grades are valued by scoring: negative (0-7), positive (8-21).'}, {'measure': 'Hospital Anxiety and Distress Scale (HADS)', 'timeFrame': '9 months from baseline', 'description': 'HADS includes two subscales for anxiety and depression, each with respective 7 items, and the grades are valued by scoring: negative (0-7), positive (8-21).'}, {'measure': 'Hospital Anxiety and Distress Scale (HADS)', 'timeFrame': '12 months from baseline', 'description': 'HADS includes two subscales for anxiety and depression, each with respective 7 items, and the grades are valued by scoring: negative (0-7), positive (8-21).'}, {'measure': 'Visual Analogue Scale (VAS) for tinnitus', 'timeFrame': '1 months from baseline', 'description': 'Visual Analogue Scale (VAS) for tinnitus is a universal psychometric scale evaluating subjective tinnintus. A total score is 10, from 0 to 10. The higher the score, the more severe the symptom.'}, {'measure': 'Visual Analogue Scale (VAS) for tinnitus', 'timeFrame': '3 months from baseline', 'description': 'Visual Analogue Scale (VAS) for tinnitus is a universal psychometric scale evaluating subjective tinnintus. A total score is 10, from 0 to 10. The higher the score, the more severe the symptom.'}, {'measure': 'Visual Analogue Scale (VAS) for tinnitus', 'timeFrame': '9 months from baseline', 'description': 'Visual Analogue Scale (VAS) for tinnitus is a universal psychometric scale evaluating subjective tinnintus. A total score is 10, from 0 to 10. The higher the score, the more severe the symptom.'}, {'measure': 'Visual Analogue Scale (VAS) for tinnitus', 'timeFrame': '12 months from baseline', 'description': 'Visual Analogue Scale (VAS) for tinnitus is a universal psychometric scale evaluating subjective tinnintus. A total score is 10, from 0 to 10. The higher the score, the more severe the symptom.'}], 'secondaryOutcomes': [{'measure': 'Athens Insomnia Scale (AIS)', 'timeFrame': '1 months from baseline', 'description': 'AIS grades three categories of sleep disorder: no insomnia scoring below 4, suspicious (4-6), insomnia (7-24)'}, {'measure': 'Athens Insomnia Scale (AIS)', 'timeFrame': '3 months from baseline', 'description': 'AIS grades three categories of sleep disorder: no insomnia scoring below 4, suspicious (4-6), insomnia (7-24)'}, {'measure': 'Athens Insomnia Scale (AIS)', 'timeFrame': '9 months from baseline', 'description': 'AIS grades three categories of sleep disorder: no insomnia scoring below 4, suspicious (4-6), insomnia (7-24)'}, {'measure': 'Athens Insomnia Scale (AIS)', 'timeFrame': '12 months from baseline', 'description': 'AIS grades three categories of sleep disorder: no insomnia scoring below 4, suspicious (4-6), insomnia (7-24)'}, {'measure': 'tinnitus loudness matched by sensation level (LM, SL)', 'timeFrame': '1 months from baseline', 'description': 'The loudness of tinnitus is reflected in sensation level (dB SL). Sensation level is defined as the loudness value above hearing threshold at the pitch of tinnitus.'}, {'measure': 'tinnitus loudness matched by sensation level (LM, SL)', 'timeFrame': '3 months from baseline', 'description': 'The loudness of tinnitus is reflected in sensation level (dB SL). Sensation level is defined as the loudness value above hearing threshold at the pitch of tinnitus.'}, {'measure': 'tinnitus loudness matched by sensation level (LM, SL)', 'timeFrame': '9 months from baseline', 'description': 'The loudness of tinnitus is reflected in sensation level (dB SL). Sensation level is defined as the loudness value above hearing threshold at the pitch of tinnitus.'}, {'measure': 'tinnitus loudness matched by sensation level (LM, SL)', 'timeFrame': '12 months from baseline', 'description': 'The loudness of tinnitus is reflected in sensation level (dB SL). Sensation level is defined as the loudness value above hearing threshold at the pitch of tinnitus.'}, {'measure': 'minimum masking level (MML)', 'timeFrame': '1 months from baseline', 'description': 'MML test is presented bilaterally, the noise is raised until tinnitus is just covered in both ears. The higher the value, the more severe the tinnitus.'}, {'measure': 'minimum masking level (MML)', 'timeFrame': '3 months from baseline', 'description': 'MML test is presented bilaterally, the noise is raised until tinnitus is just covered in both ears. The higher the value, the more severe the tinnitus.'}, {'measure': 'minimum masking level (MML)', 'timeFrame': '9 months from baseline', 'description': 'MML test is presented bilaterally, the noise is raised until tinnitus is just covered in both ears. The higher the value, the more severe the tinnitus.'}, {'measure': 'minimum masking level (MML)', 'timeFrame': '12 months from baseline', 'description': 'MML test is presented bilaterally, the noise is raised until tinnitus is just covered in both ears. The higher the value, the more severe the tinnitus.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['subjective tinnitus', 'tinnitus relieving sound', 'clinical effects'], 'conditions': ['Tinnitus, Subjective']}, 'referencesModule': {'references': [{'pmid': '23948178', 'type': 'BACKGROUND', 'citation': 'Langguth B, Kreuzer PM, Kleinjung T, De Ridder D. Tinnitus: causes and clinical management. Lancet Neurol. 2013 Sep;12(9):920-930. doi: 10.1016/S1474-4422(13)70160-1.'}, {'pmid': '21502503', 'type': 'BACKGROUND', 'citation': 'De Ridder D, Elgoyhen AB, Romo R, Langguth B. Phantom percepts: tinnitus and pain as persisting aversive memory networks. Proc Natl Acad Sci U S A. 2011 May 17;108(20):8075-80. doi: 10.1073/pnas.1018466108. Epub 2011 Apr 18.'}, {'pmid': '25273878', 'type': 'BACKGROUND', 'citation': 'Tunkel DE, Bauer CA, Sun GH, Rosenfeld RM, Chandrasekhar SS, Cunningham ER Jr, Archer SM, Blakley BW, Carter JM, Granieri EC, Henry JA, Hollingsworth D, Khan FA, Mitchell S, Monfared A, Newman CW, Omole FS, Phillips CD, Robinson SK, Taw MB, Tyler RS, Waguespack R, Whamond EJ. Clinical practice guideline: tinnitus. Otolaryngol Head Neck Surg. 2014 Oct;151(2 Suppl):S1-S40. doi: 10.1177/0194599814545325.'}, {'pmid': '22633033', 'type': 'BACKGROUND', 'citation': 'Cima RF, Maes IH, Joore MA, Scheyen DJ, El Refaie A, Baguley DM, Anteunis LJ, van Breukelen GJ, Vlaeyen JW. Specialised treatment based on cognitive behaviour therapy versus usual care for tinnitus: a randomised controlled trial. Lancet. 2012 May 26;379(9830):1951-9. doi: 10.1016/S0140-6736(12)60469-3.'}, {'pmid': '8630207', 'type': 'BACKGROUND', 'citation': 'Newman CW, Jacobson GP, Spitzer JB. Development of the Tinnitus Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1996 Feb;122(2):143-8. doi: 10.1001/archotol.1996.01890140029007.'}, {'pmid': '37268971', 'type': 'DERIVED', 'citation': 'Tang D, Wang J, Yu X, Yu H. The clinical effects of modified tinnitus relieving sound (MTRS) for chronic tinnitus: protocol for a randomized controlled trial. Trials. 2023 Jun 2;24(1):372. doi: 10.1186/s13063-023-07389-8.'}]}, 'descriptionModule': {'briefSummary': 'Objective Tinnitus is one of the most common acoustic disorders by affecting 5-43% people around the world, and tinnitus is harmful to social and individuals, inducing to annoyance, irritability, anxiety, depression, insomnia and concentration difficulties. Many efforts have been made to help tinnitus suffers, however, the curative means are still in absence. This study aims to introduce a novel sound therapy for tinnitus and to evaluate the efficacy of modified tinnitus relieving sound treatment in comparison with unmodified music which served as a control.\n\nMethods and analysis A randomized, triple-blinded, controlled, clinical trial will be carried out. 68 patients with subjective tinnitus will be recruited and randomized into two groups in 1:1 ratio. The primary outcomes will be Tinnitus Handicapped Inventory (THI), Hospital Anxiety and Distress Scale (HADS), and visual analogue scale (VAS) for tinnitus; the secondary outcome measures will be Athens Insomnia Scale (AIS), tinnitus loudness matched by sensation level (LM, SL), and minimum masking level (MML). Assessment will be performed at baseline and at 1, 3, 9, and 12 months post-randomization. The sound stimulus will be persistent until 9 months after randomization, and be interdictory in the last three months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adults aged between 18 to 80 years old;\n2. Diagnosed with subjective tinnitus;\n3. Chronic tinnitus: tinnitus course ≥3 months;\n4. Be able to understand and communicate with Mandarin；\n5. The average pure tone threshold (0.5, 1, 2kHz) ≤ 55dB HL of the worse ear;\n6. Subjects are able to understand the purpose of the study, volunteer to participate and cooperate with the instructors to complete the experiment, and be willing to sign the informed consent.\n\nExclusion Criteria:\n\n1. Pulsatile tinnitus and objective tinnitus；\n2. Having significant health issues that affect or prevent participation or continue with the follow-up;\n3. Diseases requiring other medical intervention first (eg, infections, tumors, otosclerosis, Meniere's disease, the acute stage of sudden sensorineural hearing loss);\n4. People with severe hyperacusis, severe anxiety, depression and other psychiatric disorders；\n5. Currently participating in other research projects that may affect tinnitus；\n6. Subjects who are not considered suitable for this clinical trial by the researchers."}, 'identificationModule': {'nctId': 'NCT04026932', 'briefTitle': 'The Clinical Effects of Modified TRS Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Eye & ENT Hospital of Fudan University'}, 'officialTitle': 'The Clinical Effects of Modified Tinnitus Relieving Sound Treatment', 'orgStudyIdInfo': {'id': 'Tinnitus sound therapy RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Unmodified music group', 'description': '34 participants in Group 1 will listen to the music without any modification for at least two hours a day in total.', 'interventionNames': ['Other: Listening to unmodified music']}, {'type': 'EXPERIMENTAL', 'label': 'Modified tinnitus relieving sound group', 'description': '34 participants in Group 2 will listen to the music modified according to the matched dominant tinnitus pitch for at least two hours a day in total.', 'interventionNames': ['Other: Listening to modified tinnitus relieving sound']}], 'interventions': [{'name': 'Listening to unmodified music', 'type': 'OTHER', 'description': 'Listening to unmodified music for at least 2 hours a day', 'armGroupLabels': ['Unmodified music group']}, {'name': 'Listening to modified tinnitus relieving sound', 'type': 'OTHER', 'description': 'Listening to modified tinnitus relieving sound for at least 2 hours a day', 'armGroupLabels': ['Modified tinnitus relieving sound group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200031', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Huawei Li, Phd &MD', 'role': 'CONTACT', 'email': 'hwli@shmu.edu.cn'}, {'name': 'Dongmei Tang, MD', 'role': 'CONTACT', 'email': 'tang.dongm@163.com'}, {'name': 'Huawei Li, Phd & MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dongmei Tang, Phd & MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Huiqian Yu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Dongmei Tang', 'role': 'CONTACT', 'email': 'tang.dongm@163.com', 'phone': '+86-13023299189'}, {'name': 'Huiqian Yu', 'role': 'CONTACT', 'email': 'yhq925@163.com', 'phone': '+86-13636423139'}], 'overallOfficials': [{'name': 'Huawei Li', 'role': 'STUDY_CHAIR', 'affiliation': 'Eye and ENT Hospital of Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eye & ENT Hospital of Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}