The Effects of CPAP Withdrawal on Cerebral Vascular Reactivity and Brain Oxygenation in OSA

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive
• Interventions: Device: Continuous positive airway pressure device

• Registration Number: NCT02493673
• Lead Sponsor: University of Zurich

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-30
• Study First Submitted QC: 2015-07-08
• Study First Posted: 2015-07-09
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP therapy	Continuous positive airway pressure device	Continuous positive airway pressure therapy
Sham CPAP	Continuous positive airway pressure device	Sham- Continuous positive airway pressure

Primary Outcome Measures

Name	Time	Method
Cerebrovascular reactivity (CVR)	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

Secondary Outcome Measures

Name	Time	Method
Resting heart rate	Change from baseline in resting heart rate after 2 weeks of CPAP withdrawal
Apnoea-hypopnoea-index (AHI)	Change from baseline in AHI after 2 weeks of CPAP withdrawal
Oxygen Desaturation Index (ODI)	Change from baseline in ODI after 2 weeks of CPAP withdrawal
Ambulatory morning blood pressure	Change from baseline in ambulatory morning blood pressure after 2 weeks of CPAP withdrawal

Trial Locations

Locations (1)

Pulmonary Division, University Hospital Zurich; 🇨🇭 Zurich, Switzerland