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

April 5, 2018 updated by: University of Zurich

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • Pulmonary Division, University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CPAP therapy
Continuous positive airway pressure therapy
Device: Continuous positive airway pressure device
(ResMed Spirit S8)
Sham Comparator: Sham CPAP
Sham- Continuous positive airway pressure
Device: Continuous positive airway pressure device
(ResMed Spirit S8)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline in CVR after 2 weeks of CPAP withdrawal

Secondary Outcome Measures

Outcome Measure
Time Frame
Ambulatory morning blood pressure
Time Frame: Change from baseline in ambulatory morning blood pressure after 2 weeks of CPAP withdrawal
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
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
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
Change from baseline in ODI after 2 weeks of CPAP withdrawal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Malcolm Kohler, MD, University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

June 30, 2015

First Submitted That Met QC Criteria

July 8, 2015

First Posted (Estimate)

July 9, 2015

Study Record Updates

Last Update Posted (Actual)

April 6, 2018

Last Update Submitted That Met QC Criteria

April 5, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-ZH-Nr. 2014-0684

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep Apnea, Obstructive

Clinical Trials on Continuous positive airway pressure device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe