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NCT Number: NCT07665385

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

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.

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Key information

Conditions

Chronic Subjective Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Tinnitus

Age range

18 month–65 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group A: sound therapy

Behavioral

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

Behavioral

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

Behavioral

Group C: Combined Therapy

  • Patients will receive both sound therapy and CBT simultaneously following the same protocol as above.

Primary outcomes

  1. Primary outcome: Changes in tinnitus severity

    Time frame: 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

Secondary outcomes

  1. chang in Visual Analog Scale (VAS) score

    Time frame: Baseline, immediately after completion of treatment , and 3 months after completion of treatment

    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

  2. change in Tinnitus Handicap Inventory (THI) score

    Time frame: Baseline, immediately after completion of treatment , and 3 months after completion of treatment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aya Ahmed Elsayed Abdelaal, Resident doctor

CONTACT

[email protected]

01147206609

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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