Wirth Markus, Pieper Jannik, Heller Ulrike, Bulitta Michael, Schmitz Daniel, Wollenberg Barbara, Löwenheim Hubert, Wolpert Stephan
Department of Otolaryngology, RWTH University Aachen, Aachen, Germany.
Department of Otolaryngology, Technical University of Munich, Munich, Germany.
Trials. 2025 Jun 2;26(1):184. doi: 10.1186/s13063-025-08775-0.
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.
The purpose of this study is to assess the clinical efficacy and safety of a vestibular health app for patients with vestibular vertigo.
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.
It is expected that therapy with the DTx will be statistically superior to physiotherapy in terms of effect size.
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.
German National Registry of Clinical Studies (DRKS00028026), a WHO ICRTP registry. Registered on December 12, 2023.
前庭性眩晕是导致残疾的主要原因之一。前庭性眩晕的临床标准治疗包括进行能产生中枢前庭代偿（CVC）的体育活动。家庭锻炼被视为物理治疗的一个组成部分。然而，仍需要一种可靠的解决方案来支持家庭锻炼的定期和正确执行。为此，开发了VH-90-D DiGA，这是一种用于多模块家庭治疗训练的数字疗法（DTx）。
本研究旨在评估一款用于前庭性眩晕患者的前庭健康应用程序的临床疗效和安全性。
设计了一项随机分组对照单盲临床试验（RCT）。患者将被随机分配到两个治疗组之一，并按预定顺序检查终点指标。实验组接受数字疗法（每天约15分钟，共90天），对照组按照德国法定医疗保健计划接受物理治疗（通常为6次，每次20分钟的现场物理治疗）。主要结局指标将采用经过验证的德国版眩晕症状量表简表VSS-sf-VER（0-32分）来测量眩晕强度。在第2、6和12周后进行评估。主要结局指标通过测量从基线到第12周VSS-sf评分点变化的组间差异来确定。包括失访者在内，样本量已确定为2×100。
预计数字疗法在效应量方面在统计学上优于物理治疗。
本试验方案标志着一项验证性RCT（GEVE II），用于研究数字眩晕治疗的疗效和安全性。计划中的RCT基于一系列主要和次要疗效变量。按预定顺序检查终点指标可确保验证性统计的严谨性，并应对多重性挑战。这种序贯检验会持续进行，直到达到显著性。然而，如果某个特定变量未达到显著性，则后续变量将仅在描述性基础上进行探索。
德国国家临床研究注册中心（DRKS00028026），世界卫生组织国际临床试验注册平台注册机构。于2023年12月12日注册。
