Sleep Apnea, ObstructiveNCT02493673
The Effects of CPAP Withdrawal on Cerebral Vascular Reactivity and Brain Oxygenation in OSA
A study testing Continuous positive airway pressure device in people with Sleep Apnea, Obstructive, run by University of Zurich at 1 site in Switzerland.
Trial summary
Obstructive sleep apnoea (OSA) is a highly prevalent sleep-related breathing disorder associated with adverse cardiovascular outcome. Underlying mechanisms are subject of debate. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Continuous positive airway pressure device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2015to Dec 2017
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Objectively confirmed OSA (at the time of original diagnosis) with an oxygen desaturation index (ODI) and apnoea-hypopnoea-index (AHI) of ≥20/h.
- Currently an oxygen desaturation index (≥4% dips) of ≥15/h during an ambulatory nocturnal pulse oximetry performed on the last night of a four-night period off CPAP.
- Treated with CPAP for more than 12 months
- Device usage >4h per night, >80% of the last 365 days, and AHI<10 with treatment (according to CPAP machine download data).
- Age between 20 and 75 years.
- Written informed consent as documented by signature.
Who cannot join
- Previous ischemic or haemorrhagic stroke; known cerebral aneurysm or arterio-venous malformation.
- Carotid artery stenosis > 70%
- Use of alpha- and beta-adrenergic blocking medication, antianginal medications, triptans, selective COX-inhibitors
- Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension or hypotension (>180/110 or <90/60mmHg)
- Implanted pacemaker or internal cardiac defibrillator
- Changes in medication during the trial
Show all 11Show fewer
- Previous ventilatory failure (awake SpO2 <93% andPaCO2>6kPa).
- Obesity hypoventilation syndrome, COPD
- Previously diagnosed with Cheyne-Stokes breathing.
- Current professional driver or any previous sleep related driving accidents.
- Caffeine or nicotine abuse 12 hours before measurements
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Pulmonary Division, University Hospital Zurich
Zurich, 8091
About this study
Official title: The Effects of Continuous Positive Airway Pressure Therapy Withdrawal on Cerebral Vascular Reactivity and Brain Oxygenation in Patients With Obstructive Sleep Apnoea: A Randomised Controlled Trial
Obstructive sleep apnoea (OSA) is a highly prevalent sleep-related breathing disorder associated with adverse cardiovascular outcome. Underlying mechanisms are subject of debate. A causal relationship between OSA and systemic hypertension as well as peripheral endothelial dysfunction was shown, and there is accumulating evidence from physiologic and observational studies that cerebral autoregulation is insufficient to protect the brain from the nocturnal consequences of OSA. However, there are no data from randomised controlled trials proving a causal relationship between OSA and impaired cerebral vascular reactivity (CVR). The aim of this randomised controlled trial is to study the effects of a short-term CPAP withdrawal, and thus returning OSA, on daytime CVR and brain oxygenation to establish whether there is a causal relationship between OSA and cerebral vascular damage.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Continuous positive airway pressure device
- Keywords
- Continuous Positive Airway Pressure, Stroke, Cerebrovascular reactivity, Brain oxygenation
- Medical subject headings
- Sleep Apnea, Obstructive, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressure deviceDevice
(ResMed Spirit S8)
| Study group | Role | What they receive |
|---|---|---|
| CPAP therapy | Active comparator | Continuous positive airway pressure therapy Receives: Device: Continuous positive airway pressure device |
| Sham CPAP | Sham comparator | Sham- Continuous positive airway pressure Receives: Device: Continuous positive airway pressure device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebrovascular reactivity (CVR)
CVR measured non-invasively by blood oxygen level-dependent (BOLD) magnetic resonance imaging (MRI) under controlled cardiovascular reactivity stimulation during wakefulness
Measured: Change from baseline in CVR after 2 weeks of CPAP withdrawal
Secondary outcomes (4)
Ambulatory morning blood pressure
Measured: Change from baseline in ambulatory morning blood pressure after 2 weeks of CPAP withdrawal
Resting heart rate
Measured: Change from baseline in resting heart rate after 2 weeks of CPAP withdrawal
Apnoea-hypopnoea-index (AHI)
Measured: Change from baseline in AHI after 2 weeks of CPAP withdrawal
Oxygen Desaturation Index (ODI)
Measured: Change from baseline in ODI after 2 weeks of CPAP withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malcolm Kohler, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493673
- Sponsor's protocol ID
- KEK-ZH-Nr. 2014-0684
- Status last verified
- Apr 2018
- First submitted
- 30 Jun 2015
- Last updated
- 6 Apr 2018
- Results posted
- No
Publications
Thiel S, Gaisl T, Lettau F, Boss A, Winklhofer S, Kohler M, Rossi C. Impact of hypertension on cerebral microvascular structure in CPAP-treated obstructive sleep apnoea patients: a diffusion magnetic resonance imaging study. Neuroradiology. 2019 Dec;61(12):1437-1445. doi: 10.1007/s00234-019-02292-z. Epub 2019 Sep 16.
PubMed 31529145Thiel S, Haile SR, Peitzsch M, Schwarz EI, Sievi NA, Kurth S, Beuschlein F, Kohler M, Gaisl T. Endocrine responses during CPAP withdrawal in obstructive sleep apnoea: data from two randomised controlled trials. Thorax. 2019 Nov;74(11):1102-1105. doi: 10.1136/thoraxjnl-2019-213522. Epub 2019 Aug 29.
PubMed 31467191
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Continuous Positive Airway Pressure Therapy Withdrawal on Cerebral Vascular Reactivity and Brain Oxygenation in Patients With Obstructive Sleep Apnoea: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02493673
- Acronym / sponsor ID
- KEK-ZH-Nr. 2014-0684
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Continuous Positive Airway Pressure, Stroke, Cerebrovascular reactivity, Brain oxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 9 Jul 2015 (estimated)
- 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 apnoea (OSA) is a highly prevalent sleep-related breathing disorder associated with adverse cardiovascular outcome. Underlying mechanisms are subject of debate. A causal relationship between OSA and systemic hypertension as well as peripheral endothelial dysfunction was shown, and there is accumulating evidence from physiologic and observational studies that cerebral autoregulation is insufficient to protect the brain from the nocturnal consequences of OSA. However, there are no data from randomised controlled trials proving a causal relationship between OSA and impaired cerebral vascular reactivity (CVR). The aim of this randomised controlled trial is to study the effects of a short-term CPAP withdrawal, and thus returning OSA, on daytime CVR and brain oxygenation to establish whether there is a causal relationship between OSA and cerebral vascular damage.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP therapy | Active comparator | Device: Continuous positive airway pressure deviceContinuous positive airway pressure therapy |
| Sham CPAP | Sham comparator | Device: Continuous positive airway pressure deviceSham- Continuous positive airway pressure |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Objectively confirmed OSA (at the time of original diagnosis) with an oxygen desaturation index (ODI) and apnoea-hypopnoea-index (AHI) of ≥20/h.
- Currently an oxygen desaturation index (≥4% dips) of ≥15/h during an ambulatory nocturnal pulse oximetry performed on the last night of a four-night period off CPAP.
- Treated with CPAP for more than 12 months
- Device usage >4h per night, >80% of the last 365 days, and AHI<10 with treatment (according to CPAP machine download data).
- Age between 20 and 75 years.
Key exclusion criteria (11 listed)
- Previous ischemic or haemorrhagic stroke; known cerebral aneurysm or arterio-venous malformation.
- Carotid artery stenosis > 70%
- Use of alpha- and beta-adrenergic blocking medication, antianginal medications, triptans, selective COX-inhibitors
- Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension or hypotension (>180/110 or <90/60mmHg)
- Implanted pacemaker or internal cardiac defibrillator
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 |
|---|---|---|
| Continuous positive airway pressure device(ResMed Spirit S8) | Device | CPAP therapy, Sham CPAP |
Primary outcome
Cerebrovascular reactivity (CVR)
Time frame: Change from baseline in CVR after 2 weeks of CPAP withdrawal
CVR measured non-invasively by blood oxygen level-dependent (BOLD) magnetic resonance imaging (MRI) under controlled cardiovascular reactivity stimulation during wakefulness
4 secondary outcomes
Ambulatory morning blood pressure
Time frame: Change from baseline in ambulatory morning blood pressure after 2 weeks of CPAP withdrawal
Resting heart rate
Time frame: Change from baseline in resting heart rate after 2 weeks of CPAP withdrawal
Apnoea-hypopnoea-index (AHI)
Time frame: Change from baseline in AHI after 2 weeks of CPAP withdrawal
Oxygen Desaturation Index (ODI)
Time frame: Change from baseline in ODI after 2 weeks of CPAP withdrawal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Derived from this study: PubMed 31529145Thiel S, Gaisl T, Lettau F, Boss A, Winklhofer S, Kohler M, Rossi C. Impact of hypertension on cerebral microvascular structure in CPAP-treated obstructive sleep apnoea patients: a diffusion magnetic resonance imaging study. Neuroradiology. 2019 Dec;61(12):1437-1445. doi: 10.1007/s00234-019-02292-z. Epub 2019 Sep 16.
- Derived from this study: PubMed 31467191Thiel S, Haile SR, Peitzsch M, Schwarz EI, Sievi NA, Kurth S, Beuschlein F, Kohler M, Gaisl T. Endocrine responses during CPAP withdrawal in obstructive sleep apnoea: data from two randomised controlled trials. Thorax. 2019 Nov;74(11):1102-1105. doi: 10.1136/thoraxjnl-2019-213522. Epub 2019 Aug 29.
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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.
Malcolm Kohler, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous positive airway pressure device in people with Sleep Apnea, Obstructive, run by University of Zurich 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 6 Apr 2018. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cerebrovascular reactivity (CVR) (time frame: Change from baseline in CVR after 2 weeks of CPAP withdrawal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02493673, which also lists 2 linked publications.
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 6 Apr 2018.