Night-to-Night Variability of Novel Physiological Parameters in Home Sleep Apnea Testing
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Participants with suspected or diagnosed sleep-disordered breathing of any severity will be recruited at Inselspital University Hospital und University Bern. No selection or stratification based on sex, gender, or any other patient characteristics is applied during recruitment. Participants are included consecutively based on the clinical indication for home sleep apnea testing, irrespective of sex or gender. Any resulting imbalance reflects the underlying clinical population and does not compromise the scientific validity of the study, as analyses will account for sex and gender as covariates and report their effects transparently.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
192 Participants
are grouped into 1 trial groupGroup A: All participants
Trial outcomes
Primary outcomes
1
Night-to-night variability of apnea-hypopnea index (events per hour of sleep) over 4 nights
The variability of the apnea-hypopnea index (events per hour of sleep) over 4 nights will be quantified using linear mixed-effects models, accounting for confounding variables.
Time frame
4 nights of respiratory polygraphy2
Night-to-night variability of oxygen desaturation index (events per hour of sleep) over 10 nights
The variability will be quantified using linear mixed-effects models, accounting for confounding variables.
Time frame
4 nights of respiratory polygraphy and 10 nights of oxymetry3
Night-to-night variability of hypoxic burden (minute x percent per hour of sleep) over 10 nights
The variability will be quantified using linear mixed-effects models, accounting for confounding variables.
Time frame
4 nights of respiratory polygraphy and 10 nights of oxymetry4
Night-to-night variability of ventilatory burden over 4 nights
The variability will be quantified using linear mixed-effects models, accounting for confounding variables. Ventilatory burden will be calculated according to Parekh et al.
Time frame
4 nights of respiratory polygraphySecondary outcomes
1
Identification of factors contributing to and explaining variability
Each influencing factor will be evaluated on its potential to explain the observed variability in the objective physiological parameters listed above. Each factor will be included individually as a fixed effect in the mixed-effects model and tested for significance. The following factors will be analyzed: * Age (years) * Body mass index (kg(m2) * Gender * Upper airway anatomy (tonsil size) * Mean OSA severity over all nights (of the respective parameter) * Sleep position (supine time as a percent of sleep time) * Alcohol consumption (number of drinks) * Caffeine intake (number of cups) * Nicotine use (number of packages) * Sleep Medication (free text) * Subjective sleep quality (visual analog scale, VAS, 0 to 10 points) * Snoring intensity (VAS, 0 to 10 points) * Daytime sleepiness on a VAS of the subsequent day (0 to 10 points) * Daytime sleepiness on the Epworth Sleepiness Scale of the subsequent day (0 to 24 points) * Respiratory symptoms such as infection (VAS) * Allergy symptoms
Time frame
4 nights of respiratory polygraphy and 10 nights of oxymetry2
Correlation between physiological parameters from sleep testing and patient-reported outcome measures (PROMs)
Associations between physiological metrics and PROMs will be assessed using mixed-effects models, analogously to the analysis of influencing factors above and correlation analysis (Spearman's rank coefficient). Patient-reported symptoms for correlation analyses: * Sleep quality on a VAS (0 to 10 points) * Snoring intensity on a VAS (0 to 10 points) * Daytime sleepiness on a VAS (0 to 10 points) * Epworth Sleepiness Scale (0 to 24 points)
Time frame
4 nights of respiratory polygraphy and 10 nights of oxymetrySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov