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

Sleep Apnea, Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02493673
• Other study ID #: KEK-ZH-Nr. 2014-0684
• Status: Completed
• Phase: N/A
• First received: June 30, 2015
• Last updated: April 5, 2018
• Start date: June 2015
• Est. completion date: December 2017

Study information

• Verified date: April 2018
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Continuous positive airway pressure device
(ResMed Spirit S8)

Locations

Country	Name	City	State
Switzerland	Pulmonary Division, University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebrovascular reactivity (CVR)	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	Ambulatory morning blood pressure		Change from baseline in ambulatory morning blood pressure after 2 weeks of CPAP withdrawal
Secondary	Resting heart rate		Change from baseline in resting heart rate after 2 weeks of CPAP withdrawal
Secondary	Apnoea-hypopnoea-index (AHI)		Change from baseline in AHI after 2 weeks of CPAP withdrawal
Secondary	Oxygen Desaturation Index (ODI)		Change from baseline in ODI after 2 weeks of CPAP withdrawal