Skip to main content
OpenTrials
Completed

NCT Number: NCT02493673

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Apnea, Obstructive Apnea Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Stroke Vascular Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pulmonary Division, University Hospital Zurich

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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

Treatment and study plan

Continuous positive airway pressure device

Device

(ResMed Spirit S8)

Primary outcomes

  1. 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

Secondary outcomes

  1. Ambulatory morning blood pressure

    Time frame: Change from baseline in ambulatory morning blood pressure after 2 weeks of CPAP withdrawal

  2. Resting heart rate

    Time frame: Change from baseline in resting heart rate after 2 weeks of CPAP withdrawal

  3. Apnoea-hypopnoea-index (AHI)

    Time frame: Change from baseline in AHI after 2 weeks of CPAP withdrawal

  4. Oxygen Desaturation Index (ODI)

    Time frame: Change from baseline in ODI after 2 weeks of CPAP withdrawal

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 9, 2015
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.