Unification of Treatments and Interventions for Tinnitus Patients (UNITI): a study protocol for a multi-center randomized clinical trial

Abstract

Background Tinnitus represents a relatively common condition in the global population accompanied by various comorbidities and severe burden in many cases. Nevertheless, there is currently no general treatment or cure, presumable due to the heterogeneity of tinnitus with its wide variety of etiologies and tinnitus phenotypes. Hence, most treatment studies merely demonstrated improvement in a subgroup of tinnitus patients. The majority of studies are characterized by small sample sizes, unstandardized treatments and assessments, or applications of interventions targeting only a single organ level. Combinatory treatment approaches, potentially targeting multiple systems as well as treatment personalization, might provide remedy and enhance treatment responses. The aim of the present study is to systematically examine established tinnitus therapies both alone and in combination in a large sample of tinnitus patients. Further, it wants to provide the basis for personalized treatment approaches by evaluating a specific decision support system developed as part of an EU-funded collaborative project (Unification of treatments and interventions for tinnitus patients; UNITI project). Methods/study design This is a multi-center parallel-arm randomized clinical trial conducted at five different clinical sites over the EU. The effect of four different tinnitus therapy approaches (sound therapy, structured counseling, hearing aids, cognitive behavioral therapy) applied over a time period of 12 weeks as a single or rather a combinatory treatment in a total number of 500 chronic tinnitus patients will be investigated. Assessments and interventions are harmonized over the involved clinical sites. The primary outcome measure focuses on the domain tinnitus distress assessed via the Tinnitus Handicap Inventory. Discussion Results and conclusions from the current study might not only provide an essential contribution to combinatory and personalized treatment approaches in tinnitus but could also provide more profound insights in the heterogeneity of tinnitus, representing an important step towards a cure for tinnitus. Trial registration ClinicalTrials.gov NCT04663828. Registered on 11 December 2020.

Evaluation and Management of Tinnitus: Are There Opportunities for Improvement?

“…Similarly, when told that the tinnitus that has been so bothersome is not a sign of a brain tumor or an early indication of impending dementia, patients tend to feel relieved and less anxious. Because management of tinnitus can depend largely on the mind‐set and coping mechanisms of the patient, a focus on assessment of the patient’s stress level, anxiety, tendency toward depression, and history of obsessive thinking can be important 1,46,59,60,69,70 …”

Experience of tinnitus in adults who have severe-to-profound hearing loss: A scoping review

“…All included studies used one treatment method, however due to the heterogeneity of tinnitus pathophysiology and different personal experiences, researchers are looking more into combination of treatments such as sound therapy, personalized counseling, hearing aids, and CBT. A recent multicentre clinical trial involved a comparison of the effects of the single and combination therapy, i.e., hearing aids alone or hearing aids and cognitive behavioral therapy, or hearing aids and structured counseling or hearing aids and sound therapy ( 59 ). However, it excluded participants with severe hearing loss due to barriers in communication, which again demonstrates the need for research into adapting the existent or developing new management methods for those who are Deaf or have severe-to-profound hearing loss.…”

Smartphone-Guided Educational Counseling and Self-Help for Chronic Tinnitus

“…Such an educational counseling approach aims to promote self-help capacities of the patients and enhance patient empowerment. In principle, educational counseling can be applied as a solitary therapy or in combination with other clinical interventions [ 12 ].…”