Vertidisan® (VH90D; VH-90-D)
Clinical trials of the Vertidisan® app: scientific publications and congress contributions.
Scientific Publications
PubMed
Clinical trials of the Vertidisan® app on PubMed
All scientific publications on Vertidisan (VH90D; VH-90-D) in the database of the U.S. National Library of Medicine.
Deutsches Ärzteblatt 2026 · GEVE-I Trial
The Treatment of Vertigo With a Digital Health App: Findings of the Prospective Randomized Controlled GEVE-I Trial
Markus Wirth, Jannik Pieper, Ulrike Heller, Michael Bulitta, Daniel Schmitz, Barbara Wollenberg, Anne Ruck, Hubert Löwenheim, Walter Lehmacher, Stephan Wolpert. Dtsch Arztebl Int 2026; 123: 157–62; DOI: 10.3238/arztebl.m2025.0232
Background: Vestibular vertigo is common and frequently leads to inability to work. We studied the clinical efficacy and safety of a digital health app (VH90D) for the treatment of vestibular vertigo.
Methods: We conducted a confirmatory, prospective, single-blinded, randomized, group-controlled, single-center, two-arm superiority trial with 212 participants. 106 of them (the intervention group) were treated with the app, and the other 106 (the control group) received treatment as usual with standard physiotherapy. The primary endpoint was the vertigo symptom score (VSS-sf-VER) at 12 weeks. The trial was entered into the German Clinical Trials Register (DRKS00024188).
Results: The intergroup difference in the mean change of VSS-sf-VER score from baseline to week 12 was −7.9 points (95% confidence interval: [−9.5; −6.2]; Cohen’s d: 1.55). The vertigo intensity score fell by an average of 12.7 points (clinically important difference [CID] −5 points; [−14.1; −11.2]) in the intervention group and 2.7 points (CID −5 points; [−3.7; −1.7]) in the control group (physiotherapy).
Conclusion: The digital health app VH90D markedly reduced vertigo, with greater efficacy than the median value of six 20-minute physiotherapy sessions.
Trials (Springer Nature) 2025
Digital vertigo therapy: study protocol for a confirmatory randomized controlled trial in patients with vestibular vertigo.
Wirth M, Pieper J, Heller U, Bulitta M, Schmitz D, Wollenberg B, Löwenheim H, Wolpert S. Trials. 2025 Jun 2;26(1):184. DOI: 10.1186/s13063-025-08775-0
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. 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.
Laryngol. Otol. Rhinol. (Thieme) 2024
Structured ABEV exercises for the treatment of vestibular dysfunction. (Original in German)
Benedikt P. Zenner, Daniel Schmitz, Hans-Peter Zenner, Markus Wirth. Laryngorhinootologie 2024; 103(03): 207–212. DOI: 10.1055/a-2135-5762
Introduction: The clinical standard treatment of vestibular vertigo comprises, in addition to drugs, above all physical therapy in the form of regular exercises. Vertidisan is a planned digital health application (DiGA) for structured vertigo therapy. Its content is multimodal and includes adaptive balance/eye movement and visual stimulation exercises (ABEV), which are expected to have an antivertiginous effect through neuronal learning.
Methods: A cohort study with 104 patients with intra-individual control was conducted to investigate in isolation the clinical efficacy of 16 ABEV exercises for the treatment of peripheral vestibulopathies, as they are also used in the planned DiGA Vertidisan. Using the short version VSS-sf1-VER of the vertigo-specific, validated VSS rating scale as the primary outcome variable, vertigo scores before therapy (T0) were compared with the corresponding data at the end of a period of 12–16 weeks (T1).
Results: Complete data sets at T0 and T1 were available for n=104 patients. The mean VSS-sf1-V score decreased from 3.80 (median 4, SD 0.47) to 0.92 (median 1, SD 1.19) from T0 to T1 (weeks 12–16). The result is statistically significant (p=0.001) and shows a high clinical effect size.
Conclusion: In summary, the analysis of the vertigo score shows a statistically and clinically significant reduction of vertigo through the use of the 16 ABEV guide exercises.
Scientific Congress Contributions
German ENT Congress Essen 2024
Digital therapy of vertigo with Vertidisan – first results of a prospective, semi-blinded, two-arm, confirmatory, randomized controlled clinical trial with 212 patients (GEVE-I trial).
Wirth, Heller, Ruck, von Meyer, Wollenberg, Löwenheim, Wolpert: 95th Annual Meeting of the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery, Essen. Laryngo-Rhino-Otologie 2024; 103(S02): 181
Vertidisan by Digitineers is an app with a balance training programme for use at home. The efficacy of Vertidisan against vertigo was investigated using an RCT (randomized clinical trial), the scientifically most rigorous type of clinical study, with two patient groups: the first group was treated with Vertidisan; the second received physiotherapy.
After 12 weeks, vertigo had clearly improved in 87.73% of Vertidisan users, compared with only 25.47% in the physiotherapy group. Vertidisan is therefore effective in the treatment of vertigo, and its efficacy is clearly superior to physiotherapy.
Introduction. Vestibular vertigo is widespread and among the leading causes of inability to work. The German national AWMF guidelines (2015, 2021) for vertigo recommend treatment approaches that explicitly include sensorimotor therapy. Vertidisan by Digitineers is the digital application of a multimodal, predominantly sensorimotor and optokinetic vestibular training programme. Its expected mechanism of action is the sensorimotor and optokinetic induction of central vestibular compensation (CVC), a neuronal learning process in the brain. As long as cerebral CVC activation is achieved, Vertidisan can be effective regardless of the underlying peripheral disease.
Methods. The study was designed as a confirmatory, prospective, randomized, group-controlled two-arm clinical trial (RCT) on the clinical efficacy of Vertidisan. Control patients were treated with standard statutory physiotherapy as TAU (therapy as usual). The RCT comprised N=212 ITT participants, N=106 per group. The primary efficacy variable was vertigo intensity measured with the validated German version of the VSS-sf-VER score. Inclusion criteria included objective results of the SBDT (Standard Balance Deficit Test) requiring a severity of 51 or more.
Results. ANCOVA responder analyses of the ITT population with jump-to-reference (JTR) imputation showed that after 12 weeks, 87.73% of app users were responders, compared with only 25.47% in the physiotherapy group (p<0.0001). Within the app responder group, the VSS-sf-VER vertigo intensity score fell by a statistically significant −76.15% (p<0.0001). With an average within-group vertigo improvement of −66.2% (p<0.0001), the Vertidisan group showed a significant and pronounced reduction of the VSS-sf-VER score with a clinically meaningful effect size; the TAU group showed a significantly smaller reduction of only −16.8% (p<0.0001). The confirmatory intergroup comparison revealed a highly significant (p<0.0001; Cohen’s d: 1.55) mean treatment difference, likewise with a clinically meaningful effect size.
Conclusion. Vertidisan is effective in the treatment of vertigo, and its efficacy is statistically significantly superior to physiotherapy. (Source: Wirth et al., 2024)
German ENT Congress Frankfurt 2025
Improvement of the quality of life of vertigo patients through treatment with VH90D.
Bühning, Wald, Wolpert, Meyer, Sadok, Bürklein, Rak, Löwenheim, Lang, Dietz, Hackenberg, Wollenberg, Wirth: 96th Annual Meeting of the German Society of ENT, Head and Neck Surgery, Frankfurt. HNO (2025). DOI: 10.1007/s00106-025-01624-1
Introduction: Vertigo is one of the frequent causes of disability and reduced quality of life. The digital health application VH90D (Vertidisan) was developed as a new approach to vertigo treatment.
Material/Methods: In this confirmatory randomized controlled GEVE-I trial we investigated the clinical efficacy of the German version of VH90D. Of the 212 enrolled participants, 106 received treatment as usual (TAU) and 106 used VH90D. Efficacy endpoints included improvements in vertigo-related disability, distress and quality of life (QoL), measured with validated instruments: Dizziness Handicap Inventory (DHI), Distress Thermometer (DT) and SF-36 (QoL).
Results: Compared with TAU, the use of VH90D led to significantly greater improvements in the DHI score (p<0.0001), the DT (p=0.0427) and the physical SF-36 score (p=0.0082).
Discussion: Overall, VH90D (Vertidisan) led to statistically significant improvements in vertigo-related disability and distress as well as quality of life, regardless of the specific peripheral cause of the disease. In addition, VH90D showed statistically significant superiority compared with physiotherapy.
German ENT Congress Frankfurt 2025
Randomized, controlled, multicentre GEVE-II trial on the treatment of peripheral vertigo with the VERTIDISAN app in 259 patients.
Meyer, Sadok, Wolpert, Bühning, Wald, Bürklein, Rak, Löwenheim, Lang, Dietz, Hackenberg, Wollenberg, Wirth: 96th Annual Meeting of the German Society of ENT, Head and Neck Surgery, Frankfurt. HNO (2025). DOI: 10.1007/s00106-025-01624-1
In plain language: A clinical trial was conducted at several university hospitals. The use of Vertidisan can lead to a reduction or even the disappearance of vertigo.
Scientific summary: With an average improvement of 67.93% (p<0.0001), Meyer et al. showed a significant improvement of vertigo for the Vertidisan group. In comparison, the control group (physiotherapy) showed a significantly smaller change of only 23.95%. The confirmatory group comparison revealed a highly significant treatment effect of Vertidisan (adjusted LSMean −6.4 score points, 95% confidence interval −8 to −4.8 score points, p<0.001). Responder analyses showed that after 12 weeks, 83.6% of Vertidisan users were responders, compared with only 36.6% in the physiotherapy group (p<0.001).
Conclusion: The multicentre GEVE-II trial once again confirmed the efficacy of Vertidisan in the treatment of vertigo: a statistically significant and clinically meaningful reduction of vertigo through the use of the app, and statistically significant, clinically meaningful superiority over physiotherapy.
German ENT Congress Ulm 2026
Longitudinal study of central vertigo compensation by means of app-controlled, non-invasive, optokinetic and sensorimotor brain stimulation.
Ilgner, Heller, Meyer, Sadok, Wolpert, Bühning, Wald, Bürklein, Rak, Schmitz, Löwenheim, Lang, Dietz, Hackenberg, Wollenberg, Wirth.
Introduction: Vertidisan is an app for non-invasive, digital, optokinetic and sensorimotor brain stimulation aiming at central vestibular compensation. To investigate long-term efficacy in vertigo patients, a prospective randomized group-controlled trial (RCT) with 212 patients was conducted.
Material and methods: The experimental group received Vertidisan (app group) for three months; the control group started with physiotherapy (TAU group) for three months and then received the app for three months. Six efficacy measurements (T1–T6) were performed up to one year after the individual start with the app using the Vertigo Symptom Score (VSS) and the Dizziness Handicap Index (DHI). Endpoints were analysed by ANCOVA.
Results: The long-term study of the treatment of chronic vertigo with the Vertidisan app shows: therapy results remain stable for 12 months. After 12 months, a high and clinically meaningful symptom reduction was still demonstrable: 71.8% mean reduction from baseline; the responder rate was 94%. The responder rate even increased slightly and continuously over the entire observation period – an indication of ongoing neuroplastic adaptation processes of central vertigo compensation in the vestibular system.
Discussion: The results show a long-term benefit of app-based vertigo therapy for patients with peripheral vertigo. Vertidisan thus enables effective long-term therapy of chronic vertigo.
German ENT Congress Ulm 2026
Efficacy of a medical app in different specific vestibulopathies with vertigo – results of the confirmatory, randomized, group-controlled GEVE-I trial.
Sadok, Meyer, Heller, Wolpert, Bühning, Wald, Bürklein, Rak, Schmitz, Löwenheim, Lang, Dietz, Hackenberg, Wollenberg, Wirth.
Introduction: Vestibular vertigo is one of the most frequent causes of years lived with disability and considerable reductions in quality of life. For peripheral vestibular forms of vertigo there is as yet no evidence-based causal drug therapy. The Vertidisan app is a CE-marked digital therapeutic (DTx) offering a multimodal sensorimotor and optokinetic home training programme to induce central vestibular compensation (CVC).
Material and methods: The prospective, single-blinded, randomized, group-controlled GEVE-I trial comprised N = 212 patients (106 per group). The intervention group completed a twelve-week Vertidisan training; the control group received standard physiotherapy (TAU). The primary efficacy variable was the change in vertigo intensity (VSS-sf-VER; MCID: 4.8). Analysis was performed by ANCOVA.
Results:
Discussion: The GEVE-I trial demonstrates the significant efficacy and safety of the Vertidisan app in the treatment of peripheral vestibular vertigo. Digital therapy represents an effective, safe and patient-centred complement to standard physiotherapy.
