NCT01797653CompletedNot Applicable
The Effects of CPAP-withdrawal on Microvascular Function in Patients With Obstructive Sleep Apnea: A Randomized-controlled Trial
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Zurich
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- hyperaemic myocardial blood flow
Study Overview
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) therapy withdrawal on myocardial perfusion and dermal and renal microvascular function during a 2 week period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 >
- •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
Arms & Interventions
Placebo CPAP
Placebo Comparator
patients established on CPAP therapy, who are randomized to the placebo comparator, will use a CPAP device with subtherapeutic pressure during two weeks.
Intervention: CPAP therapy withdrawal (Other)
therapeutic CPAP
Active Comparator
patients who are randomized to the active comparator, will continue with CPAP treatment with therapeutic pressure during two weeks
Intervention: Continue CPAP treatment (Procedure)
Outcomes
Primary Outcomes
hyperaemic myocardial blood flow
Time Frame: 2 weeks
Secondary Outcomes
- Coronary flow reserve(2 weeks)
- Urine albumine excretion rate(2 weeks)
- Dermal microvascular vasodilatory response(2 weeks)
Investigators
Study Sites (1)
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