Aesyra SA, a Swiss medtech company developing innovative digital therapeutics for dental and sleep-related disorders, recently announced the successful completion of its clinical investigation evaluating the efficacy and safety of AesyBite Active, an intelligent oral appliance designed to treat and prevent sleep bruxism through biofeedback.
The clinical investigation demonstrated that AesyBite Active achieved a statistically significant and clinically meaningful reduction in sleep bruxism activity, exceeding the predefined performance target.
Strong and robust clinical outcomes
In the study (Identifier: NCT06153810), involving 26 adult patients with confirmed sleep bruxism, activation of the AesyBite Active biofeedback system resulted in a 60.6% reduction in total sleep bruxism duration per hour compared to baseline (95% CI: 55.8%–64.9%, p < 0.001). This reduction exceeded the study’s predefined efficacy threshold, confirming the device’s ability to meaningfully reduce bruxism activity during sleep.
In addition to the primary endpoint, statistically significant improvements were observed across multiple secondary measures, including:
- Reduced number of bruxism episodes per hour
- Shorter bruxism episode duration
- Lower intensity of bruxism episodes
- No negative impact on sleep duration
The therapeutic effect was consistent regardless of baseline bruxism severity and independent of the timing of biofeedback activation.
Positive safety and usability profile
No adverse events were reported during the investigation. Patient-reported outcomes showed progressive improvements in orofacial pain, as well as improved comfort and acceptance of the device over time, supporting its suitability for long-term nightly use.
A differentiated approach to treating sleep bruxism
Unlike conventional passive splints, AesyBite Active combines a customized oral appliance with embedded sensors and active biofeedback, enabling real-time detection and reduction of bruxism activity without disturbing sleep.
“These results represent a major milestone for Aesyra,” said Marco Letizia, co-founder and CEO of Aesyra SA. “Demonstrating a consistent and robust reduction in sleep bruxism activity, together with an excellent safety profile, strongly supports the clinical value of AesyBite Active and its potential to change how sleep bruxism is treated.”
“The magnitude and consistency of the effect observed in this investigation are particularly encouraging,” added Prof. Marcello Maddalone, Principal Investigator, University of Milano-Bicocca.
“The data support AesyBite Active as an effective and well-tolerated therapeutic option for patients suffering from sleep bruxism.”
