biostudies-literatureDavies CNICHD NIH HHSNCATS NIH HHS2703-2712https://www.ebi.ac.uk/biostudies/studies/S-EPMC9713912biostudies-literatureUnknown18(12)<h4>Study objectives</h4>Evaluate per-patient diagnostic performance of a wireless dual-sensor system (ANNE sleep) compared with reference standard polysomnography (PSG) for the diagnosis of moderate and severe obstructive sleep apnea (OSA) with a minimum prespecified threshold of 80% for both sensitivity and specificity.<h4>Methods</h4>A multicenter clinical trial was conducted to evaluate ANNE sleep vs PSG to diagnose moderate and severe OSA in individuals 22 years or older. For each testing approach, apnea-hypopnea index (AHI) was manually scored and averaged by 3 registered sleep technologists blinded to the other system. Average variations > 15% were adjudicated by a sleep medicine physician.<h4>Results</h4>In a total of n = 225 participants (mean age 53 years, range 22-88 years), PSGJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep MedicineA single-arm, open-label, multicenter, and comparative study of the ANNE sleep system vs polysomnography to diagnose obstructive sleep apnea.PMC9713912UL1 TR001422K12 HD050121Kim DPower TYu LCziraky MRangel SMMiller JZee PGill KKalluri LCooksey JHarty BJStanek EPark JEdel CRan DSWalter JBlake SLee JYSchauer JLim AToloui OXu SOlagbenro MOSerao ADavies CfalseA single-arm, open-label, multicenter, and comparative study of the ANNE sleep system vs polysomnography to diagnose obstructive sleep apnea.<h4>Study objectives</h4>Evaluate per-patient diagnostic performance of a wireless dual-sensor system (ANNE sleep) compared with reference standard polysomnography (PSG) for the diagnosis of moderate and severe obstructive sleep apnea (OSA) with a minimum prespecified threshold of 80% for both sensitivity and specificity.<h4>Methods</h4>A multicenter clinical trial was conducted to evaluate ANNE sleep vs PSG to diagnose moderate and severe OSA in individuals 22 years or older. For each testing approach, apnea-hypopnea index (AHI) was manually scored and averaged by 3 registered sleep technologists blinded to the other system. Average variations > 15% were adjudicated by a sleep medicine physician.<h4>Results</h4>In a total of n = 225 participants (mean age 53 years, range 22-88 years), PSG2022-01-01T00:00:00Z2022 Dec2026-06-17T06:39:41.759Z2025-05-29T21:47:19.885ZS-EPMC97139123593492610.5664/jcsm.10194