Background Tinnitus is a leading cause of disease burden globally. Several therapeutic strategies are recommended in guidelines for the reduction of tinnitus distress; however, little is known about the potentially increased effectiveness of a combination of treatments and personalized treatments for each tinnitus patient. Methods Within the Unification of Treatments and Interventions for Tinnitus Patients project, a multicenter, randomized clinical trial is conducted with the aim to compare the effectiveness of single treatments and combined treatments on tinnitus distress (UNITI-RCT). Five different tinnitus centers across Europe aim to treat chronic tinnitus patients with either cognitive behavioral therapy, sound therapy, structured counseling, or hearing aids alone, or with a combination of two of these treatments, resulting in four treatment arms with single treatment and six treatment arms with combinational treatment. This statistical analysis plan describes the statistical methods to be deployed in the UNITI-RCT. Discussion The UNITI-RCT trial will provide important evidence about whether a combination of treatments is superior to a single treatment alone in the management of chronic tinnitus patients. This pre-specified statistical analysis plan details the methodology for the analysis of the UNITI trial results. Trial registration ClinicalTrials.gov NCT04663828. The trial is ongoing. Date of registration: December 11, 2020. All patients that finished their treatment before 19 December 2022 are included in the main RCT analysis.
Background Tinnitus is a leading cause of disease burden globally. Several therapeutic strategies are recommended in guidelines for the reduction of tinnitus distress; however, little is known about the potential increased effectiveness of a combination of treatments and personalized treatments for each tinnitus patient. Methods Within the Unification of Treatments and Interventions for Tinnitus Patients project, a multicenter, randomized clinical trial is conducted with the aim to compare the effectiveness of single treatments and combined treatments on tinnitus distress (UNITI-RCT). Five different tinnitus centers across Europe aim to treat chronic tinnitus patients with either cognitive behavior therapy, sound therapy, structured counseling, or hearing aids alone, or with a combination of two of these treatments, resulting in 4 treatment arms with single treatment and 6 treatment arms with combinational treatment. This statistical analysis plan describes the statistical methods to be deployed in the UNITI-RCT. Discussion The UNITI-RCT trial will provide important evidence about whether a combination of treatments is superior to a single treatment alone in the management of chronic tinnitus patients. This pre-specified statistical analysis plan details the methodology for the analysis of the UNITI trial results. Trial registration ClinicalTrials.gov NCT04663828 (https://clinicaltrials.gov/ct2/show/NCT04663828). The trial is ongoing. Date of registration: December 11, 2020. The main RCT analyses will start by the end of December 2022 and will include data from patients who have finished their treatment by the 19th of December 2022.
Optimization of dietary intake is an essential component in the multidimensional effort to prevent and manage chronic disease. Recently, demand has increased for nutrition-focused management strategies for chronic tinnitus. The primary aim of this study was to evaluate 10 dietary items for their association with changes in subjective tinnitus severity. A secondary aim was to develop an algorithm to better identify those individuals who might benefit from dietary modification strategies. A total of 5017 anonymous users of the TinnitusTalk forum completed an online survey regarding how various dietary items affected the severity of their tinnitus. Results suggest that, while intake of caffeine [positive effect (PE): 0.4%; negative effect (NE): 16.2%], alcohol (PE: 2.7%; NE: 13.3%, and salt (PE: 0.1%; NE: 9.9%) was most likely to influence tinnitus severity, it did so only for a small proportion of participants and reported effects were most commonly mild. Further, though a classification algorithm was able to leverage participant demographic, comorbidity, and tinnitus characteristics to identify those individuals most likely to benefit from dietary modification above chance levels, further efforts are required to achieve significant clinical utility. Taken together, these results do not support dietary modification as a primary treatment strategy for chronic tinnitus in the general population, though clinically meaningful effects might be observable in certain individuals.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.