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Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Tinnitus | Study protocol

Establishing a Core Domain Set for early-phase clinical trials of electrical stimulation interventions for tinnitus in adults: protocol for an online Delphi study

Authors: Bas Labree, Derek J. Hoare, Kathryn Fackrell, Deborah A. Hall, Lauren E. Gascoyne, Magdalena Sereda

Published in: Trials | Issue 1/2022

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Abstract

Background

Tinnitus is the awareness of a sound in the ear or head in the absence of an external source. It affects around 10–15% of people and current treatment options are limited. Experimental treatments include various forms of electrical stimulation of the brain. Currently, there is no consensus on the outcomes that should be measured when investigating the efficacy of this type of intervention for tinnitus. This study seeks to address this by establishing a Core Domain Set: a common standard of what specific tinnitus-related complaints are critical and important to assess in all clinical trials of electrical stimulation-based interventions for tinnitus.

Methods

A two-round online survey will be conducted, followed by a stakeholder consensus meeting to identify a Core Domain Set. Participants will belong to one of two stakeholder groups: healthcare users with lived experience of tinnitus, and professionals with relevant clinical, commercial, or research experience.

Discussion

This study will establish a Core Domain Set for the evaluation of electrical stimulation-based interventions for tinnitus via an e-Delphi study. The resulting Core Domain Set will act as a minimum standard for reporting in future clinical trials of electrical stimulation interventions for tinnitus. Standardisation will facilitate comparability of research findings.
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Metadata
Title
Establishing a Core Domain Set for early-phase clinical trials of electrical stimulation interventions for tinnitus in adults: protocol for an online Delphi study
Authors
Bas Labree
Derek J. Hoare
Kathryn Fackrell
Deborah A. Hall
Lauren E. Gascoyne
Magdalena Sereda
Publication date
01-12-2022
Publisher
BioMed Central
Keyword
Tinnitus
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-07020-2

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