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 intervention 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 counselling, 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

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

Trials ◽

10.1186/s13063-021-05835-z ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Stefan Schoisswohl ◽

Berthold Langguth ◽

Martin Schecklmann ◽

Alberto Bernal-Robledano ◽

Benjamin Boecking ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Hearing Aids ◽

Behavioral Therapy ◽

Primary Outcome Measure ◽

Small Sample ◽

Personalized Treatment ◽

Treatment Approaches ◽

Multiple Systems ◽

Small Sample Sizes

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.

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Randomization

Critical Thinking in Clinical Research ◽

10.1093/med/9780199324491.003.0005 ◽

2018 ◽

pp. 87-104

Author(s):

Juliana C Ferreira ◽

Ben M. W. Illigens ◽

Felipe Fregni

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Randomized Clinical Trial ◽

Selection Bias ◽

Allocation Concealment ◽

Small Sample ◽

Adaptive Randomization ◽

Entire Process ◽

Advantages And Disadvantages ◽

Small Sample Sizes

Chapter 5 gives the reader an overview of a major important feature in every randomized clinical trial: the process of randomization. This chapter describes the main features of randomization, its importance, advantages, and disadvantages. It also discusses the most common methods of randomization (simple randomization, blocked randomization, stratified randomization, adaptive randomization), as well as what the investigator should take into consideration when choosing among these options. In this scenario, the challenges of defining a method in clinical trials with small sample sizes are also discussed. Additionally, the chapter explores the consequences that may arise from lack of randomization, such as selection bias. It also focuses on defining allocation concealment and its importance to the appropriate conduction of a study. In this chapter, the reader is taken through the entire process—from choosing a suitable randomization option to ensuring the appropriate implementation of the selected method.

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