The primary objective is to evaluate the relative effectiveness of fixed CPAP in comparison to APAP in reducing arterial blood pressure in patients with resistant hypertension and obstructive sleep apnea (OSA). The secondary objectives are: a) to evaluate the relative effectiveness of fixed CPAP versus APAP in improving arterial stiffness, sleep-disordered breathing, sleep quality, inflammatory markers and glucose regulation; b) to identify specific characteristic of persons who respond to the two CPAP modalities in order to identify which device is better for each subject.
The confirmatory hypothesis is that subjects with resistant hypertension and OSA will show a greater degree of blood pressure reduction after 6 weeks of treatment with fixed CPAP in comparison to those treated with APAP. Explanatory and exploratory hypotheses are that a greater reduction in arterial stiffness will be noted when compared with the benefit in blood pressure, that reductions in arterial stiffness will be associated with benefits to serum measurements of inflammatory markers and glucose regulation, and that control of sleep apnea and the attendant improvement in sleep quality will be better with fixed CPAP than APAP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
34
Royal Victoria Hospital
Montreal, Quebec, Canada
Montreal General Hospital
Montreal, Quebec, Canada
24 hour blood pressure.
Time frame: 6 weeks and 12 weeks after initial intervention
Non-invasive measures of arterial stiffness using applanation tonometry.
Time frame: 6 weeks and 12 weeks after initial intervention
Standard measures of OSA severity, including AHI and measures of nocturnal oxygenation and sleep quality using polysomnography.
Time frame: 6 weeks and 12 weeks after initial intervention
Blood tests to assess levels of aldosterone, hsCRP, fasting glucose, HbA1c, and plasma insulin.
Time frame: 6 weeks and 12 weeks after initial intervention
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