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Clinical Trial — Recruiting Now

🔬 Active Clinical Trial: NCT07665385 | Status: NOT_YET_RECRUITING | Phase: NA

View full trial details on ClinicalTrials.gov →

Direct Comparison of Sound and Psychological Therapy for Tinnitus Begins

Researchers are preparing to launch a clinical trial to answer a specific question: which is more effective for chronic tinnitus, a therapy that changes what you hear, or one that changes how you think about the sound? The study, titled “Efficacy of Sound Therapy, Cognitive Behavioral Therapy and Their Combination in Management of Chronic Tinnitus,” will directly compare these two common approaches, alone and together, in 60 patients. For the millions who experience the persistent ringing or buzzing of tinnitus, the results could clarify which treatment path offers the most relief for the distress and life impact it causes.

Key Takeaways

  • The trial will directly compare Sound Therapy, Cognitive Behavioral Therapy (CBT), and their combination in 60 adults with chronic tinnitus.
  • Its primary goal is to determine which method best reduces tinnitus severity and improves psychological wellbeing.
  • Researchers hypothesize that the combined approach may lead to superior patient outcomes.
  • The trial is not yet recruiting participants, who must have had tinnitus for over 3 months and stable psychological health.
  • Results could provide evidence to help clinicians and patients choose between established tinnitus management strategies.

How the Trial Will Work

The study has a clear, three-group design. After screening, participants will be randomly assigned to one of three intervention groups. Group A will receive Sound Therapy. This method uses external sounds—potentially including white noise, nature sounds, or customized soundscapes—to reduce the perceptual contrast between the tinnitus and the patient’s acoustic environment. The aim is to promote neural habituation, making the phantom sound less noticeable over time.

Group B will receive Cognitive Behavioral Therapy (CBT). This psychological intervention does not aim to eliminate the tinnitus sound itself, but to alter the negative emotional and cognitive reactions to it. Therapists work with patients to identify and modify maladaptive thought patterns and behaviors linked to their tinnitus, thereby reducing distress and improving coping mechanisms.

Group C will receive a combined regimen of both CBT and Sound Therapy. Researchers, referencing work by Hall and others, suggest this integrated approach may produce better results than either therapy in isolation.

The trial will measure outcomes across several areas, focusing on changes in tinnitus severity, psychological wellbeing, and overall quality of life. By measuring these factors across all three groups, the study aims to isolate the specific benefits attributable to each therapeutic method.

Scientific Rationale and Patient Eligibility

The study is built on the understanding that chronic subjective tinnitus is a complex, multifactorial condition. There is no universal cure. Current clinical management, as noted by the investigators, focuses primarily on reducing the perception of tinnitus and minimizing the distress associated with it.

Sound Therapy and CBT represent two distinct angles of attack on the problem, one auditory and one psychological. This trial seeks to move beyond using these therapies in isolation by testing them in a controlled, comparative format. The hypothesis is that simultaneously addressing both the perceptual and the reactive components of tinnitus may offer a more complete solution.

The researchers are looking for 60 adult participants between the ages of 18 and 65. To keep the study group consistent, eligible patients must have chronic subjective tinnitus lasting more than three months. They must also have normal hearing or only mild to moderate sensorineural hearing loss. A stable general and psychological condition is required.

The exclusion criteria are specific. Individuals under 18 or over 65 cannot participate. Those with severe hearing loss, objective tinnitus (caused by a vascular or muscular source), active psychiatric disorders requiring immediate care, or active middle or external ear diseases are also excluded.

Current Status and Potential Impact

As of now, the trial status is NOT_YET_RECRUITING. The team is in the preparatory stages before opening enrollment to eligible participants.

The potential implications of this study are practical. For patients, clear evidence on the relative effectiveness of Sound Therapy versus CBT could inform shared decision-making with their audiologists or therapists. It could help answer whether to start with one approach, or to seek out a combined treatment program from the outset. For clinicians, the results would provide data to support more personalized treatment recommendations. For the field of tinnitus research, a head-to-head comparison adds valuable data to a body of literature that often examines these therapies separately. It tests the practical value of an integrated treatment model in a real-world clinical setting.

Outcomes will be measured in terms of patient-reported severity, distress, and life impact. Success won’t be defined by silencing the tinnitus, but by significantly turning down its volume on daily life.

This article is for informational purposes only. Consult a qualified professional for personalised advice.


Source:
Trial of Management of Chronic Tinnitus by Sound Therapy and Cognitive Behavioral Therapy (ClinicalTrials.gov: NCT07665385)

Medical Disclaimer

This article is for informational purposes only and does not constitute medical advice. The research summaries presented here are based on published studies and should not be used as a substitute for professional medical consultation. Always consult a qualified healthcare provider before making any changes to your health regimen.

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