An interventional study of Group A: sound therapy and Group B: Cognitive Behavioral Therapy in Chronic Subjective Tinnitus, sponsored by Sohag University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Months to 65 Months. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Sohag University · Not applicable, Interventional, and Treatment
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:
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
444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 368 interventional studies indexed under Tinnitus.
Browse Tinnitus studies →Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.
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o Age: 18-65 years.
Exclusion Criteria:
o Age: \<18, >65 years
Behavioral: Group A: sound therapy
Behavioral: Group B: Cognitive Behavioral Therapy
Behavioral: Group A: sound therapy · Behavioral: Group B: Cognitive Behavioral Therapy · Behavioral: Group C: Combined CBT + 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 (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 Therapy • Patients will receive both sound therapy and CBT simultaneously following the same protocol as above.
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
Time frame: Baseline, immediately after completion of treatment , and 3 months after completion of treatment
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
Time frame: Baseline, immediately after completion of treatment , and 3 months after completion of treatment
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.
Time frame: Baseline, immediately after completion of treatment , and 3 months after completion of treatment
Plan to share: Undecided — No decision has been made regarding the sharing of individual participant data at this time
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Sep 2026, 3 months later.
Of 133 non-industry interventional studies with no phase under Tinnitus, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 3 months is below that.
Counting every sponsor, half of 151 studies reached it within 17 months; a quarter within 10 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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