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

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

*Corresponding author for this work

    Research output: Contribution to journalArticlepeer-review

    23 Downloads (Pure)

    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.
    Original languageEnglish
    Article number1039
    JournalTrials
    Volume23
    DOIs
    Publication statusPublished - 21 Dec 2022

    Keywords

    • Tinnitus
    • Neuromodulation
    • Core Domain Set

    ASJC Scopus subject areas

    • Pharmacology (medical)
    • Medicine (miscellaneous)

    Fingerprint

    Dive into the research topics of 'Establishing a Core Domain Set for early-phase clinical trials of electrical stimulation interventions for tinnitus in adults: protocol for an online Delphi study'. Together they form a unique fingerprint.

    Cite this