Obstructive Sleep ApneaOSAVENCT05920083
Obstructive Sleep Apnea - Autonomic and Vascular Exploration
A study testing CPAP withdrawal in people with Obstructive Sleep Apnea, run by Raphael Heinzer at 1 site in Switzerland.
Trial summary
The goal of this clinical trial is to assess the effect of CPAP withdrawal on vascular and autonomic function in patients with obstructive sleep apnea. The main question it aims to answer is: Is the pulse wave amplitude index able to predict the impact of sleep apnea treatment withdrawal (continuous positive airway… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- CPAP withdrawal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Jan 2024to 11 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Age ≥18 years old
- Diagnosed with OSA (AHI ≥15 events/h), confirmed during screening period
- Adequately treated with CPAP therapy for ≥6 months
- Able to give informed consent as documented by signature
Who cannot join
- Professional drivers will be excluded from the study because temporary withdrawal of CPAP may induce drowsiness.
- We will also exclude patients with conditions that may affect endothelial and autonomic function:
- Known Diabetes
- Known heart failure
- Known chronic kidney disease
- Pregnant or lactating women
Show all 12Show fewer
- Morbid obesity (≥40 kg/m2)
- Known Excessive alcohol consumption
- Known Dementia (especially dementia with Lewy bodies). (61)
- Patients using alpha and beta blockers
- Known atrial fibrillation
- Inability to follow the procedures of the study due to language problems or psychological disorders.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Lausanne University Hospital
Lausanne, Canton of Vaud, 1012
About this study
Official title: Noctural Pulse Waves Variations in OSA as a Predictor of Autonomic and Vascular Response to CPAP Therapy
The goal of this clinical trial is to assess the effect of CPAP withdrawal on vascular and autonomic function in patients with obstructive sleep apnea. The main question it aims to answer is:
- Is the pulse wave amplitude index able to predict the impact of sleep apnea treatment withdrawal (continuous positive airway pressure, CPAP) on endothelial function and baroreflex sensitivity?
Participants will stop using their CPAP for 2 weeks and the investigators will assess vascular and autonomic function before and after the withdrawal. Researchers will compare endothelial and autonomic function at baseline and after 2 weeks of withdrawal to see if there are differences. Moreover, they will assess the association between pulse wave amplitude drop profile and effect of CPAP withdrawal.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- CPAP withdrawal
- Keywords
- OSA, CPAP
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP withdrawalOther
2 weeks of CPAP withdrawal
| Study group | Role | What they receive |
|---|---|---|
| CPAP withdrawal | Experimental | CPAP withdrawal for 2 weeks Receives: Other: CPAP withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in flow-mediated dilation
Endothelial function as measured with flow-mediated dilation
Measured: Between FMD measured after 2 weeks of CPAP withdrawal and FMD measured after 2 weeks on CPAP
Change in the slope of baroreflex sensitivity
Autonomic function as measure with the slope of BRS
Measured: Between BRS measured after 2 weeks of CPAP withdrawal and BRS measured after 2 weeks on CPAP
Secondary outcomes (4)
Arterial stiffness assessed by the pulse transit time
arterial stiffness measured by the pulse transit time
Measured: Baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP
Nocturnal heart rate variability indices (linear and non linear)
HRV measured on the ECG of polygraphy
Measured: baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP
Change in heart rate response to the cold pressure test
delta heart rate before and after cold pressure test
Measured: baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP
Hypoxic burden
hypoxic burden of sleep apnea based on polysomnography
Measured: baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start12 Jan 2024
- Primary completion11 Sep 2024
- Study completion11 Sep 2024
Why it stopped: Difficulty recruiting desired number of participant.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- one group, before-after design
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raphael Heinzer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Raphael Heinzer, University of Lausanne Hospitals
- Investigators
- Raphael Heinzer, Pr., Principal investigator, Centre hospitalier universitaire vaudois (CHUV)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920083
- Sponsor's protocol ID
- 01012023
- Acronym
- OSAVE
- Status last verified
- Dec 2025
- First submitted
- 6 Jun 2023
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noctural Pulse Waves Variations in OSA as a Predictor of Autonomic and Vascular Response to CPAP Therapy
- ClinicalTrials.gov ID
- NCT05920083
- Acronym / sponsor ID
- OSAVE / 01012023
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSA, CPAP
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting desired number of participant.
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Raphael HeinzerUniversity, hospital or other
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 11 Sep 2024 (actual)
- Study completion
- 11 Sep 2024 (actual)
- First posted
- 27 Jun 2023 (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.
The goal of this clinical trial is to assess the effect of CPAP withdrawal on vascular and autonomic function in patients with obstructive sleep apnea. The main question it aims to answer is:
- Is the pulse wave amplitude index able to predict the impact of sleep apnea treatment withdrawal (continuous positive airway pressure, CPAP) on endothelial function and baroreflex sensitivity?
Participants will stop using their CPAP for 2 weeks and the investigators will assess vascular and autonomic function before and after the withdrawal. Researchers will compare endothelial and autonomic function at baseline and after 2 weeks of withdrawal to see if there are differences. Moreover, they will assess the association between pulse wave amplitude drop profile and effect of CPAP withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- one group, before-after design
| Arm | Type | Receives |
|---|---|---|
| CPAP withdrawal | Experimental | Other: CPAP withdrawalCPAP withdrawal for 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years old
- Diagnosed with OSA (AHI ≥15 events/h), confirmed during screening period
- Adequately treated with CPAP therapy for ≥6 months
- Able to give informed consent as documented by signature
Key exclusion criteria (12 listed)
- Professional drivers will be excluded from the study because temporary withdrawal of CPAP may induce drowsiness.
- We will also exclude patients with conditions that may affect endothelial and autonomic function:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP withdrawal2 weeks of CPAP withdrawal | Other | CPAP withdrawal |
Primary outcome
Change in flow-mediated dilation
Time frame: Between FMD measured after 2 weeks of CPAP withdrawal and FMD measured after 2 weeks on CPAP
Endothelial function as measured with flow-mediated dilation
Change in the slope of baroreflex sensitivity
Time frame: Between BRS measured after 2 weeks of CPAP withdrawal and BRS measured after 2 weeks on CPAP
Autonomic function as measure with the slope of BRS
4 secondary outcomes
Arterial stiffness assessed by the pulse transit time
Time frame: Baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP
Nocturnal heart rate variability indices (linear and non linear)
Time frame: baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP
Change in heart rate response to the cold pressure test
Time frame: baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP
Hypoxic burden
Time frame: baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP
Results and safety
The study was stopped early (reason given: Difficulty recruiting desired number of participant.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- 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. This study is not recruiting at the moment.
Raphael Heinzer, Pr. principal investigator
Centre hospitalier universitaire vaudois (CHUV)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP withdrawal in people with Obstructive Sleep Apnea, run by Raphael Heinzer 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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 12 Dec 2025. 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?
The study was stopped early (reason given: Difficulty recruiting desired number of participant.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in flow-mediated dilation (time frame: Between FMD measured after 2 weeks of CPAP withdrawal and FMD measured after 2 weeks on CPAP). The study lists 2 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 12 Dec 2025.