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Starting soon Not applicable

Trial of Management of Chronic Tinnitus by Sound Therapy and Cognitive Behavioral Therapy

NCT07665385 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-06-10
Last updated
2026-06-30

Condition(s) studied

Chronic Subjective Tinnitus

Investigational drug(s) / intervention(s)

Group A: sound therapyGroup B: Cognitive Behavioral TherapyGroup C: Combined CBT + Sound Therapy

Group A: sound therapy: 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: 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

Group C: Combined CBT + Sound Therapy: Group C: Combined Therapy • Patients will receive both sound therapy and CBT simultaneously following the same protocol as above.

Study 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.

Eligibility

Sex
ALL
Min age
18 Months
Max age
65 Months
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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

Primary outcome measure(s)

  • Primary outcome: Changes in tinnitus severity — Baseline, immediately after completion of treatment , and 3 months after completion of treatment
    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

Trial sites (1)

FacilityCityRegionStatus
Sohag faculty of medicine Sohag Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07665385 on ClinicalTrials.gov ↗ ← All trials in Egypt