Digital vertigo therapy: study protocol for a confirmatory randomized controlled trial in patients with vestibular vertigo

Trials, vol. 26, pp. 184

Abstract

BACKGROUND: Vestibular vertigo is one of the leading causes of disability. The clinical standard of care for vestibular vertigo includes physical activity producing central vestibular compensation (CVC). Home exercises are considered an integral part of physical therapy. However, a reliable solution is still needed to support the regular and correct execution of home exercises. For this purpose, VH-90-D DiGA was developed, which is a digital therapeutic (DTx) for multimodular in-home therapeutic training. OBJECTIVE: The purpose of this study is to assess the clinical efficacy and safety of a vestibular health app for patients with vestibular vertigo. METHODS: A randomized group-controlled single-blinded clinical trial (RCT) has been designed. Patients will be randomly assigned to one of two treatment groups and the endpoints examined in a pre-determined order. The experimental group receives the DTx (around 15 min/daily for 90 days), and the control receives physiotherapy according to the German statutory health care plan (usually 6 × 20 min of live physiotherapy). The primary outcome will be vertigo intensity measured using the German version of the validated Vertigo Symptom Scale-short form VSS-sf-VER (0-32 score points). Evaluation is performed after 2, 6, and 12 weeks. Primary outcomes are determined by measuring the group differences of the VSS-sf-score point changes from baseline to week twelve. Including dropouts, the sample size has been determined to be 2 × 100. EXPECTED RESULTS: It is expected that therapy with the DTx will be statistically superior to physiotherapy in terms of effect size. DISCUSSION: This trial protocol marks a confirmatory RCT (GEVE II) to investigate the efficacy and safety of a digital vertigo treatment. The planned RCT is based on a series of primary and secondary efficacy variables. Examination of the endpoints in a pre-determined order ensures the rigor of confirmatory statistics and addresses the challenge of multiplicity. This sequential testing continues until significance is achieved. However, if a specific variable fails to reach significance, subsequent variables will be explored solely on a descriptive basis. TRIAL REGISTRATION: German National Registry of Clinical Studies (DRKS00028026), a WHO ICRTP registry. Registered on December 12, 2023.

Authors 8

1. Markus Wirth corresponding Aachen Department of Otolaryngology

   RWTH Aachen University · Technical University of Munich

   Affiliation as printed

   Department of Otolaryngology, RWTH University Aachen, Aachen, Germany. mwirth@ukaachen.de

   Department of Otolaryngology, Technical University of Munich, Munich, Germany. mwirth@ukaachen.de

2. Jannik Christian Pieper

   WHU – Otto Beisheim School of Management

   Affiliation as printed

   Chair of Economic and Social Policy, Otto Beisheim School of Management, Koblenz-Vallendar, Germany

3. Ulrike Heller

   University of Tübingen

   Affiliation as printed

   Tübingen Study Center, Clinic of Otolaryngology, Tübingen, Germany

4. Michael Bulitta
   Affiliation as printed

   CRM Biometrics, Bornheim, Germany

5. Daniel Schmitz
   Affiliation as printed

   CRM Biometrics, Bornheim, Germany

6. Barbara Wollenberg

   Technical University of Munich

   Affiliation as printed

   Department of Otolaryngology, Technical University of Munich, Munich, Germany

7. Hubert Löwenheim

   University of Tübingen

   Affiliation as printed

   Department of Otolaryngology, University of Tübingen, Tübingen, Germany

8. Stephan Wolpert

   University of Tübingen

   Affiliation as printed

   Department of Otolaryngology, University of Tübingen, Tübingen, Germany