The Treatment of Vertigo With a Digital Health App: Findings of the Prospective Randomized Controlled GEVE-I Trial
Abstract
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.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 212 participants or records.
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