[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644250":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":31,"studyPopulation":20,"armGroups":32,"interventions":46,"overallOfficials":20,"centralContacts":60,"locations":66,"responsibleParty":80,"collaborators":20,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":20,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":20,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":109,"whyStopped":20,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Sohag University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Primary outcome: Changes in tinnitus severity","Assessment of tinnitus severity using the Tinnitus Functional Index (TFI) . Higher scores indicate greater tinnitus severity. the TFI total score ranges from 0 to 100, with higher score s indicating greater tinnitus severity and functional impact","Baseline, immediately after completion of treatment , and 3 months after completion of treatment",[14,17],{"measure":15,"description":16,"timeFrame":12},"chang in Visual Analog Scale (VAS) score","Assessment of tinnitus severity using the Visual Analog Scale (VAS) . the VAS score ranges from 0 to 10, with 0 indicate no tinnitus and 10 indicates the worst imaginable tinnitus. higher scores indicating greater tinnitus severity",{"measure":18,"description":19,"timeFrame":12},"change in Tinnitus Handicap Inventory (THI) score","Assessment of tinnitus-related handicap and quality of life using Tinnitus Handicap Inventory (THI). the THI total score ranges from 0 to 100, with higher scores indicating greater tinnitus-related handicap and poorer quality of life.",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":24,"primaryPurpose":25,"observationalModel":20,"timePerspective":20,"maskingInfo":26},"RANDOMIZED","PARALLEL","Model Description","TREATMENT",{"masking":27,"maskingDescription":28,"whoMasked":29},"SINGLE","Masking Description",[30],"PARTICIPANT","Because of the multifactorial nature of tinnitus, its effective management requires a multidisciplinary approach. While there is no single pullet mechanism of cure, current treatment strategies primary focus on reducing tinnitus related perception and minimizing its associated distress through auditory and psychological interventions.\n\nAmong these approaches, is the Sound Therapy which aims to decrease the contrast between tinnitus and related neural activity by introducing external sounds, which facilitates habituation and reducing tinnitus perception .\n\nIn contrast, Cognitive Behavioral Therapy (CBT) targets the patient's cognitive and emotional reaction to tinnitus by modifying maladaptive thoughts and behaviors, there by improving coping strategies and reducing tinnitus-related distress (Andersson, 2011). Recent evidence suggests that combining both modalities may provide superior outcomes compared to either approach alone, highlighting the potential value for integrated treatment strategies in tinnitus management (Hall et",[33,38,42],{"label":34,"type":35,"description":20,"interventionNames":36},"Group A: patients will receive Sound Therapy","ACTIVE_COMPARATOR",[37],"Behavioral: Group A: sound therapy",{"label":39,"type":35,"description":20,"interventionNames":40},"Group B: patients will receive Cognitive Behavioral Therapy (CBT).",[41],"Behavioral: Group B: Cognitive Behavioral Therapy",{"label":43,"type":35,"description":20,"interventionNames":44},"Group C: patients will receive Combined CBT + Sound Therapy.",[37,41,45],"Behavioral: Group C: Combined CBT + Sound Therapy",[47,52,56],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":20},"BEHAVIORAL","Group A: sound therapy","Group A: Sound Therapy\n\n* Patients will receive individualized sound therapy using broadband noise or tinnitus maskers.\n* Daily use recommended for 2-4 hours\u002Fday.\n* Duration: 6 weeks.\n* Patient will be instructed on habituation-based listening techniques",[34,43],{"type":48,"name":53,"description":54,"armGroupLabels":55,"otherNames":20},"Group B: Cognitive Behavioral Therapy","Group B: Cognitive Behavioral Therapy (CBT)\n\n• Structured CBT program consisting of 6 sessions over 6 weeks.\n\nEach session categorization:\n\n* Psychoeducation about tinnitus\n* Cognitive restructuring of negative thoughts\n* Relaxation techniques (breathing exercises, muscle relaxation)\n* Attention diversion strategies\n* Sleep hygiene education",[39,43],{"type":48,"name":57,"description":58,"armGroupLabels":59,"otherNames":20},"Group C: Combined CBT + Sound Therapy","Group C: Combined Therapy\n\n• Patients will receive both sound therapy and CBT simultaneously following the same protocol as above.",[43],[61],{"name":62,"role":63,"phone":64,"phoneExt":20,"email":65},"Aya Ahmed Elsayed Abdelaal, Resident doctor","CONTACT","01147206609","princess.aya1297@gmail.com",[67],{"facility":68,"status":20,"city":69,"state":20,"zip":20,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Sohag faculty of medicine","Sohag","Egypt","EG",{"type":73,"coordinates":74},"Point",[75,76],31.69478,26.55695,{"lat":76,"lon":75},[79],{"name":62,"role":63,"phone":64,"phoneExt":20,"email":65},{"type":81,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Aya Ahmed Elsayed","Resident at Audio-Vestibular unit ENT department at Sohag university hospital","100644250","trial-of-management-of-chronic-tinnitus-by-sound-therapy-and-cognitive-behavioral-therapy-100644250",false,"NCT07665385","Trial of Management of Chronic Tinnitus by Sound Therapy and Cognitive Behavioral Therapy","Efficacy of Sound Therapy, Cognitive Behavioral Therapy and Their Combination in Management of Chronic Tinnitus","Inclusion Criteria:\n\n* o Age: 18-65 years.\n\n  * Hearing level: Patients with normal hearing or mild to moderate sensorineural hearing loss (to ensure homogeneity of the sample) (National Institute for Health and Care Excellence, 2020)\n  * Complaint: patients with chronic subjective tinnitus (\\> 3 months).\n  * Psychological state: Patients with stable general and psychological condition.\n\nExclusion Criteria:\n\n* o Age: \\\u003C18, \\>65 years\n\n  * Hearing level: Patients with severe hearing loss not suitable for sound therapy\n  * Complaint: Objective tinnitus (vascular or muscular origin)\n  * Psychological state: Patients with active psychiatric disorders requiring immediate intervention.\n  * Active middle or external ear disease","ALL","18 Months","65 Months",{"count":95,"type":96},60,"ESTIMATED","INTERVENTIONAL",[99],"NA","clinical trial: The main aim of this study is to compare the effectiveness of Cognitive Behavioral Therapy (CBT) and Sound Therapy, both individually and in combination, in the management of patients with chronic subjective tinnitus and to evaluate their impact on decreasing tinnitus severity, psychological wellbeing and quality of life.\n\nPatients will be randomly divided into three groups:\n\n* Group A: patients will receive Sound Therapy.\n* Group B: patients will receive Cognitive Behavioral Therapy (CBT).\n* Group C: patients will receive Combined CBT + Sound Therapy.",[102],"Chronic Subjective Tinnitus",[104,105,106,107,108],"Sound Therapy","Cognitive Behavioral Therapy","Chronic Tinnitus","Subjective Tinnitus","Tinnitus","NOT_YET_RECRUITING","2026-06-26",{"date":112,"type":113},"2026-06-30","ACTUAL",{"date":115,"type":96},"2026-06-10",{"date":117,"type":96},"2026-12-10",{"name":5,"class":6},1]