Obstructive ApneaN2N-OSANCT07555119
Night-to-Night Variability of Novel Physiological Parameters in Home Sleep Apnea Testing
An observational study of Obstructive Apnea and Diagnostic, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Apnea, Diagnostic, Sleep Apnea Syndrome (OSAS)
- How many people
- 192 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Jul 2026to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital University Hospital and University Bern
Bern, 3010
Samuel Tschopp, MD, 0041 31 632 29 41, hno-poliklinik@insel.ch
About this study
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, Diagnostic, Sleep Apnea Syndrome (OSAS)
- Keywords
- Home Sleep Apnea Testing
- Medical subject headings
- Sleep Apnea, Obstructive, Disease, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 nights of respiratory polygraphy and 10 nights of oxymetry
Secondary outcomes (2)
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
Measured: 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:
- 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)
Measured: 4 nights of respiratory polygraphy and 10 nights of oxymetry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start24 Jul 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive ApneaStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555119
- Sponsor's protocol ID
- 2026-00237
- Acronym
- N2N-OSA
- Status last verified
- Jul 2026
- First submitted
- 16 Apr 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Night-to-Night Variability of Novel Physiological Parameters in Home Sleep Apnea Testing
- ClinicalTrials.gov ID
- NCT07555119
- Acronym / sponsor ID
- N2N-OSA / 2026-00237
- Conditions
- Obstructive Apnea, Diagnostic, Sleep Apnea Syndrome (OSAS)
- Keywords
- Home Sleep Apnea Testing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 24 Jul 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Night-to-night variability of apnea-hypopnea index (events per hour of sleep) over 4 nights
Time frame: 4 nights of respiratory polygraphy
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.
Night-to-night variability of oxygen desaturation index (events per hour of sleep) over 10 nights
Time frame: 4 nights of respiratory polygraphy and 10 nights of oxymetry
The variability will be quantified using linear mixed-effects models, accounting for confounding variables.
Night-to-night variability of hypoxic burden (minute x percent per hour of sleep) over 10 nights
Time frame: 4 nights of respiratory polygraphy and 10 nights of oxymetry
The variability will be quantified using linear mixed-effects models, accounting for confounding variables.
Night-to-night variability of ventilatory burden over 4 nights
Time frame: 4 nights of respiratory polygraphy
The variability will be quantified using linear mixed-effects models, accounting for confounding variables. Ventilatory burden will be calculated according to Parekh et al.
Night-to-night variability of heart rate variability over 10 nights
Time frame: 4 nights of respiratory polygraphy and 10 nights of oxymetry
The variability will be quantified using linear mixed-effects models, accounting for confounding variables.
Night-to-night variability of pulse wave amplitude drops (events per hour) over 10 nights
Time frame: 4 nights of respiratory polygraphy and 10 nights of oxymetry
The variability will be quantified using linear mixed-effects models, accounting for confounding variables.
2 secondary outcomes
Identification of factors contributing to and explaining variability
Time frame: 4 nights of respiratory polygraphy and 10 nights of oxymetry
Correlation between physiological parameters from sleep testing and patient-reported outcome measures (PROMs)
Time frame: 4 nights of respiratory polygraphy and 10 nights of oxymetry
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Inselspital University Hospital and University Bern
Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Apnea and Diagnostic, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Night-to-night variability of apnea-hypopnea index (events per hour of sleep) over 4 nights (time frame: 4 nights of respiratory polygraphy). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.