ABSTRACT
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.
Subject(s)
Cognitive Behavioral Therapy , Tinnitus , Humans , Combined Modality Therapy , Anesthetics, Local , EuropeABSTRACT
Auditory evoked potentials (AEPs) are brain-derived electrical signals, following an auditory stimulus, utilised to examine any obstructions along the brain neural-pathways and to diagnose hearing impairment. The clinical evaluation of AEPs is based on the measurements of the latencies and amplitudes of waves of interest; hence, their identification is a prerequisite for AEP analysis. This process has proven to be complex, as it requires relevant clinical experience, and the existing software for this purpose has little practical use. The aim of this study was the development of two automated annotation tools for ABR (auditory brainstem response)- and AMLR (auditory middle latency response)-tests. After the acquisition of 1046 raw waveforms, appropriate pre-processing and implementation of a four-stage development process were performed, to define the appropriate logical conditions and steps for each algorithm. The tools' detection and annotation results, regarding the waves of interest, were then compared to the clinicians' manual annotation, achieving match rates of at least 93.86%, 98.51%, and 91.51% respectively, for the three ABR-waves of interest, and 93.21%, 92.25%, 83.35%, and 79.27%, respectively, for the four AMLR-waves. The application of such tools in AEP analysis is expected to assist towards an easier interpretation of these signals.
ABSTRACT
Current evidence on efficacy of hearing aids (HAs) on tinnitus perception and annoyance is considered insufficient due to the heterogeneity of tinnitus characteristics and of methods used in the relevant clinical studies. This is a scoping review focused on the methodological aspects of clinical studies evaluating the value of HA fitting as part of tinnitus management over the past 10 years. Thirty-four studies were included in the review, showing important heterogeneity in almost all aspects of inclusion criteria, comparators, outcome measures, follow-up time and HA fitting procedures. Although all studies show that HA fitting has a positive impact on tinnitus perception in patients with hearing loss, the methodological heterogeneity does not allow robust conclusions. Future studies taking into account the different nature and goals of each tinnitus therapeutic modality and adapting their methods, endpoints and timelines according to them could lay the groundwork for obtaining high-quality evidence on whether and how HA fitting shall be implemented in tinnitus management strategies.
ABSTRACT
Although a wide range of tinnitus management interventions is currently under research and a variety of therapeutic interventions have already been applied in clinical practice, no optimal and universal tinnitus treatment has been reached yet. This fact is to some extent a consequence of the high heterogeneity of the methodologies used in tinnitus related clinical studies. In this manuscript, we have identified, summarized, and critically appraised tinnitus-related randomized clinical trials since 2010, aiming at systematically mapping the research conducted in this area. The results of our analysis of the 73 included randomized clinical trials provide important insight on the identification of limitations of previous works, methodological pitfalls or gaps in current knowledge, a prerequisite for the adequate interpretation of current literature and execution of future studies.
