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Not yet recruiting NCT07665385

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

No phase Interventional Chronic Subjective Tinnitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Group A: sound therapy, Group B: Cognitive Behavioral Therapy, Group C: Combined CBT + Sound Therapy.
Who it may be relevant to
Registry conditions: Chronic Subjective Tinnitus. Basic parameters: 18 months — 65 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy of Sound Therapy, Cognitive Behavioral Therapy and Their Combination in Management of Chronic Tinnitus

Overview

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.

Detailed description

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.

Among 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 .

In 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

Interventions

  • Behavioral 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
  • Behavioral 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
  • Behavioral 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.

Primary outcome measures

  • Primary outcome: Changes in tinnitus severity [Time frame: Baseline, immediately after completion of treatment , and 3 months after completion of treatment]
Secondary outcome measures (2)
  • chang in Visual Analog Scale (VAS) score [Time frame: Baseline, immediately after completion of treatment , and 3 months after completion of treatment]
  • change in Tinnitus Handicap Inventory (THI) score [Time frame: Baseline, immediately after completion of treatment , and 3 months after completion of treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Sohag faculty of medicine — Sohag

Identifiers

NCT: NCT07665385 · Soh-Med-26-5-8MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗