Clinical Trial: Real-World Performance and Safety of Apneal Dx for Sleep Apnea Screening

U.S., Sept. 10 -- ClinicalTrials.gov registry received information related to the study (NCT07809633) titled 'Real-World Performance and Safety of Apneal Dx for Sleep Apnea Screening' on Sept. 03.

Brief Summary: Sleep apnea-hypopnea syndrome (SAHS) is a frequent and largely under-diagnosed sleep-related breathing disorder. Adult prevalence is estimated between 9% and 38%. Untreated SAHS increases cardiometabolic and neurocognitive risk. Reference diagnostic methods (in-lab polysomnography and ambulatory ventilatory polygraphy) have limited capacity, which delays care.

Apneal Dx is a Class IIa software as a medical device (CE-marked 10 June 2026). It measures cardiorespiratory sleep activity using the sensors of a standard smartphone worn ...