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Digital vertigo therapy: study protocol for a confirmatory randomized controlled trial in patients with vestibular
Markus Wirth1,2, Jannik Pieper3, Ulrike Heller4
1Department of Otolaryngology, RWTH University Aachen, Aachen, Germany. mwirth@ukaachen.de.
Trials
|June 1, 2025
Summary
This study assesses a digital therapeutic app for vestibular vertigo, expecting it to be more effective than traditional physiotherapy for improving vertigo symptoms and patient outcomes.
Area of Science:
- Neurology
- Digital Health
- Rehabilitation Medicine
Background:
- Vestibular vertigo is a leading cause of disability, impacting patient quality of life.
- Current treatment involves physical activity for central vestibular compensation (CVC), with home exercises being crucial.
- A need exists for reliable digital solutions to support consistent and correct home-based vestibular rehabilitation.
Purpose of the Study:
- To evaluate the clinical efficacy and safety of a novel digital therapeutic (DTx) application for managing vestibular vertigo.
- To compare the effectiveness of a digital vestibular health app against standard physiotherapy.
Main Methods:
- A randomized, group-controlled, single-blinded clinical trial (RCT) involving 200 patients.
- Patients were assigned to either the DTx group (90-day daily use) or a control group receiving standard physiotherapy.
- Primary outcome: vertigo intensity measured by the Vertigo Symptom Scale-short form (VSS-sf-VER) at 2, 6, and 12 weeks.
Main Results:
- The study anticipates that the digital therapeutic (DTx) will demonstrate statistically superior efficacy compared to traditional physiotherapy.
- Expected findings suggest a greater effect size in vertigo symptom reduction for the DTx group.
Conclusions:
- This confirmatory RCT (GEVE II) protocol is designed to rigorously investigate the efficacy and safety of digital vertigo treatment.
- Sequential testing of efficacy variables ensures statistical rigor and addresses multiplicity challenges.
- The trial aims to establish the digital therapeutic as a viable and effective treatment option for vestibular vertigo.
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