Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Participants will undergo repeated sleep testing using respiratory polygraphy over 4 nights and oximetry over 10 nights, starting in parallel. Before and after the recordings they will fill out symptom questionnaires and patient-reported outcome measures. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 nights of respiratory polygraphy |
| 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. | 4 nights of respiratory polygraphy and 10 nights of oxymetry |
| 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. | 4 nights of respiratory polygraphy and 10 nights of oxymetry |
| 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. | 4 nights of respiratory polygraphy |
| Night-to-night variability of heart rate variability over 10 nights | The variability will be quantified using linear mixed-effects models, accounting for confounding variables. | 4 nights of respiratory polygraphy and 10 nights of oxymetry |
| Night-to-night variability of pulse wave amplitude drops (events per hour) over 10 nights | The variability will be quantified using linear mixed-effects models, accounting for confounding variables. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inselspital University Hospital and University Bern | Bern | 3010 | Switzerland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Study Protocol Synopsis | Feb 1, 2026 | Apr 15, 2026 | Prot_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study Protocol | Feb 1, 2026 | Apr 22, 2026 | Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D004194 | Disease |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
Not provided
Not provided
Not provided
Not provided
Not provided
| 4 nights of respiratory polygraphy and 10 nights of oxymetry |
| 4 nights of respiratory polygraphy and 10 nights of oxymetry |
| 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:
| 4 nights of respiratory polygraphy and 10 nights of oxymetry |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |