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

Recruiting now

Conditions studied: Obstructive Apnea, Diagnostic, Sleep Apnea Syndrome (OSAS)

In brief

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.

Key facts

Study ID

NCT07555119

Run by

Insel Gruppe AG, University Hospital Bern

People needed

192

Starts

2026-07-24

Expected to finish

2027-06-30

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Age <18 years
• Known or suspected neurological sleep disorder (e.g., narcolepsy, parasomnia)
• Known or suspected psychiatric sleep disorder
• Known or suspected central and complex sleep apnea
• Participants who are unable to perform sleep measurements reliably
• Insufficient knowledge of the project language (German)
• Inability to give consent
• Shift workers (with shift work <2 weeks before testing)

Where it is running

• Inselspital University Hospital and University Bern — Bern, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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