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

Primary Purpose

Sleep Apnea, Obstructive

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Continuous positive airway pressure device

About this trial

This is an interventional other trial for Sleep Apnea, Obstructive focused on measuring Continuous Positive Airway Pressure, Stroke, Cerebrovascular reactivity, Brain oxygenation

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Pulmonary Division, University Hospital Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

CPAP therapy

Sham CPAP

Arm Description

Continuous positive airway pressure therapy

Sham- Continuous positive airway pressure

Outcomes

Primary Outcome Measures

Cerebrovascular reactivity (CVR)

CVR measured non-invasively by blood oxygen level-dependent (BOLD) magnetic resonance imaging (MRI) under controlled cardiovascular reactivity stimulation during wakefulness

Secondary Outcome Measures

Ambulatory morning blood pressure

Resting heart rate

Apnoea-hypopnoea-index (AHI)

Oxygen Desaturation Index (ODI)

Full Information

NCT ID

NCT02493673

First Posted

June 30, 2015

Last Updated

April 5, 2018

Sponsor

University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT02493673

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

June 2015 (undefined)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Zurich

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea, Obstructive

Keywords

Continuous Positive Airway Pressure, Stroke, Cerebrovascular reactivity, Brain oxygenation

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CPAP therapy

Arm Type

Active Comparator

Arm Description

Continuous positive airway pressure therapy

Arm Title

Sham CPAP

Arm Type

Sham Comparator

Arm Description

Sham- Continuous positive airway pressure

Intervention Type

Device

Intervention Name(s)

Continuous positive airway pressure device

Intervention Description

(ResMed Spirit S8)

Primary Outcome Measure Information:

Title

Cerebrovascular reactivity (CVR)

Description

CVR measured non-invasively by blood oxygen level-dependent (BOLD) magnetic resonance imaging (MRI) under controlled cardiovascular reactivity stimulation during wakefulness

Time Frame

Change from baseline in CVR after 2 weeks of CPAP withdrawal

Secondary Outcome Measure Information:

Title

Ambulatory morning blood pressure

Time Frame

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

Title

Resting heart rate

Time Frame

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

Title

Apnoea-hypopnoea-index (AHI)

Time Frame

Change from baseline in AHI after 2 weeks of CPAP withdrawal

Title

Oxygen Desaturation Index (ODI)

Time Frame

Change from baseline in ODI after 2 weeks of CPAP withdrawal

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Malcolm Kohler, MD

Organizational Affiliation

University of Zurich

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pulmonary Division, University Hospital Zurich

City

Zurich

ZIP/Postal Code

8091

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

31529145

Citation

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.

Results Reference

derived

PubMed Identifier

31467191

Citation

Thiel 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.

Results Reference

derived

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

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