Clinical Trial

Night-to-Night Variability of Novel Physiological Parameters in Home Sleep Apnea Testing

Study acronym: N2N-OSA
Recruiting
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Summary
Obstructive sleep apnea (OSA) is usually diagnosed from a single night of home sleep apnea testing using the apnea-hypopnea index (AHI). However, the AHI varies substantially from night to night, undermining diagnostic accuracy, and shows only modest correlation with symptoms. This variability further limits its usefulness for predicting cardiovascular and other complications. Besides the traditional AHI, more robust physiological markers are needed. Several emerging physiological metrics - hypoxic burden, ventilatory burden, heart rate variability, autonomic arousals, and the pulse wave amplitude drop index - capture the physiological impact of OSA more comprehensively and demonstrate stronger associations with cardiovascular risk. Despite this promise, their night-to-night variability has not been studied. A systematic evaluation of both established and novel OSA metrics across nights is essential to identify reliable, stable parameters suitable for clinical routine. This improves diagnostic precision beyond what traditional metrics can provide, enhances patient selection, reduces costs and patient harm, and may improve treatment outcomes.
Protocol Amendment History 1 change
critical Recruitment opened 2026-07-30
Trial Details
NCT Number NCT07555119
Lead Sponsor Insel Gruppe AG, University Hospital Bern
Conditions Obstructive Apnea, Diagnostic, Sleep Apnea Syndrome (OSAS)
Enrollment 192 participants
Start Date 2026-07-24
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-29