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

NCT07555119 | Not Yet Recruiting

• 1 other identifier: 2026-00237
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Apnea; Sleep Apnea Syndrome (OSAS); Diagnostic

Keywords

Home Sleep Apnea Testing

Outcome Measures

Primary Outcomes (6)

• 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.

  4 nights of respiratory polygraphy and 10 nights of oxymetry

Secondary Outcomes (2)

• Identification of factors contributing to and explaining variability

  4 nights of respiratory polygraphy and 10 nights of oxymetry

• Correlation between physiological parameters from sleep testing and patient-reported outcome measures (PROMs)

  4 nights of respiratory polygraphy and 10 nights of oxymetry

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

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)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital University Hospital and University Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Disease; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 29, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)