Status:
COMPLETED
Randomized-controlled Trial (RCT) on CPAP-withdrawal and Microvascular Function in OSA
Lead Sponsor:
University of Zurich
Conditions:
Obstructive Sleep Apnoea
Eligibility:
All Genders
20-75 years
Phase:
NA
Brief Summary
Randomized controlled trial (therapeutic vs. placebo CPAP) including 46 patients with obstructive sleep apnea (OSA) to define the physiological effects of continuous positive airway pressure (CPAP) th...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Objectively confirmed OSA (at the time of original diagnosis) with an oxygen desaturation index (ODI, =4% dips) of \>20/h and an ESS of \>10.
- Currently \>20/h oxygen desaturations (=4% dips) during an ambulatory nocturnal pulse oximetry performed at the end of a 4-night period without CPAP.
- Treated with CPAP for more than 12 months, minimum compliance 4h per night, AHI\<10 with treatment (according to CPAP machine download data).
- Current ESS \<10.
- Exclusion criteria:
- Previous ventilatory failure (awake SpO2 \<93% and PaCO2\>6kPa).
- Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension or hypotension (\>180/110 or \<90/60mmHg)
- Previously diagnosed with Cheyne-Stokes breathing.
- Current professional driver; Any previous sleep related accident.
- Age \<20 or \>75 years at trial entry.
- Acute inflammatory disease
Exclusion
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01797653
Start Date
February 1 2013
End Date
December 1 2013
Last Update
December 23 2013
Active Locations (1)
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1
University Hospital Zurich, Division of Pneumology
Zurich, Canton of Zurich, Switzerland, 8091