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
1 other identifier
interventional
60
1 country
1
Brief Summary
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. Patients will be randomly divided into three groups:
- Group A: patients will receive Sound Therapy.
- Group B: patients will receive Cognitive Behavioral Therapy (CBT).
- Group C: patients will receive Combined CBT + Sound Therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 10, 2026
CompletedFirst Submitted
Initial submission to the registry
June 11, 2026
CompletedFirst Posted
Study publicly available on registry
June 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 10, 2026
June 30, 2026
June 1, 2026
3 months
June 11, 2026
June 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
chang in Visual Analog Scale (VAS) score
Baseline, immediately after completion of treatment , and 3 months after completion of treatment
change in Tinnitus Handicap Inventory (THI) score
Baseline, immediately after completion of treatment , and 3 months after completion of treatment
Study Arms (3)
Group A: patients will receive Sound Therapy
ACTIVE COMPARATORGroup B: patients will receive Cognitive Behavioral Therapy (CBT).
ACTIVE COMPARATORGroup C: patients will receive Combined CBT + Sound Therapy.
ACTIVE COMPARATORInterventions
Group C: Combined Therapy • Patients will receive both sound therapy and CBT simultaneously following the same protocol as above.
Group A: Sound Therapy * Patients will receive individualized sound therapy using broadband noise or tinnitus maskers. * Daily use recommended for 2-4 hours/day. * Duration: 6 weeks. * Patient will be instructed on habituation-based listening techniques
Group B: Cognitive Behavioral Therapy (CBT) • Structured CBT program consisting of 6 sessions over 6 weeks. Each session categorization: * Psychoeducation about tinnitus * Cognitive restructuring of negative thoughts * Relaxation techniques (breathing exercises, muscle relaxation) * Attention diversion strategies * Sleep hygiene education
Eligibility Criteria
You may qualify if:
- o Age: 18-65 years.
- 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)
- Complaint: patients with chronic subjective tinnitus (\> 3 months).
- Psychological state: Patients with stable general and psychological condition.
You may not qualify if:
- o Age: \<18, \>65 years
- Hearing level: Patients with severe hearing loss not suitable for sound therapy
- Complaint: Objective tinnitus (vascular or muscular origin)
- Psychological state: Patients with active psychiatric disorders requiring immediate intervention.
- Active middle or external ear disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sohag Universitylead
Study Sites (1)
Sohag faculty of medicine
Sohag, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Masking Description
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident at Audio-Vestibular unit ENT department at Sohag university hospital
Study Record Dates
First Submitted
June 11, 2026
First Posted
June 24, 2026
Study Start
June 10, 2026
Primary Completion (Estimated)
September 10, 2026
Study Completion (Estimated)
December 10, 2026
Last Updated
June 30, 2026
Record last verified: 2026-06