[removed]Discover Medical Devices[/removed], an Israeli medical devices start-up, successfully finished its first clinical trial with the SomnuSeal, an intraoral self-adaptable mask that addresses CPAP noncompliance.
The SomnuSeal mask is placed between the gums and cheeks (intraorally). The aim of the mask study was to evaluate the efficacy and convenience of the SomnuSeal oral mask in patients with moderate-severe OSA.
Ten healthy volunteers slept with the SomnuSeal mask for 1 night, and 20 patients with moderate-severe OSA (RDI >20) slept with it for up to 14 nights. In all patients, the mask was connected to an AutoPAP machine with a heated humidifier. Efficacy (respiratory indices), convenience (questionnaire), and compliance (usage meter) were monitored in all patients.
According to results in a company statement, all 10 healthy volunteers had no problems using the mask (open to the air). Of the 20 OSA patients (19 males, 1 female, age 54±11years, BMI 31.2±5.6 kg/m2, RDI 49±15/h), 10 were CPAP noncompliant (untreated patients), 3 struggled with their CPAP, and 7 were well-treated patients.
