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NCT07555119
Night-to-Night Variability of Novel Physiological Parameters in Home Sleep Apnea Testing
Conditions: Obstructive Apnea, Diagnostic, Sleep Apnea Syndrome (OSAS)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 192
Sponsor: Insel Gruppe AG, University Hospital Bern
Location: Inselspital University Hospital and University Bern Bern
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.
Eligibility Criteria
Inclusion Criteria:
* Patients with suspected or diagnosed sleep-disordered breathing, irrespective of disease severity, as defined by the indications for home sleep apnea testing in the German guidelines \[15\]
* No active treatment during sleep recordings or within preceding two weeks (e.g., mandibular advancement devices, positive airway pressure therapy)
* Written informed consent obtained
Exclusion Criteria:
* Age \
Source: ClinicalTrials.gov (NCT07555119). StuddyBuddy aggregates publicly available trial information.