Effect of Continuous Positive Airway Pressure (CPAP) Versus Auto-titrating Continuous Positive Airway Pressure (APAP) on Resistant Hypertension (HTN) and Arterial Stiffness
Recruitment status was Recruiting
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.
Obstructive Sleep Apnea
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of Fixed Versus Auto-titrating Continuous Positive Airway Pressure on Blood Pressure and Arterial Stiffness in Patients With Resistant Hypertension and Obstructive Sleep Apnea|
- 24 hour blood pressure. [ Time Frame: 6 weeks and 12 weeks after initial intervention ] [ Designated as safety issue: No ]
- Non-invasive measures of arterial stiffness using applanation tonometry. [ Time Frame: 6 weeks and 12 weeks after initial intervention ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Blood tests to assess levels of aldosterone, hsCRP, fasting glucose, HbA1c, and plasma insulin. [ Time Frame: 6 weeks and 12 weeks after initial intervention ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||January 2011|
|Estimated Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Active Comparator: auto-titrating
Patients being treated for 6 weeks with auto-titrating continuous airway pressure.
6 weeks of treatment with auto-titrating positive airway pressure
Other Name: auto-titrating airway pressure
Active Comparator: Fixed
Patients receiving 6 weeks of treatment with fixed continuous positive airway pressure.
6 weeks treatment with fixed CPAP
Other Name: Continuous Positive Airway Pressure
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044355
|Contact: Stella S Daskalopoulou, MD, MSc, PhD||514-934-1934 ext firstname.lastname@example.org|
|Contact: Richard John Kimoff, MD, FRCP(C)||514-934-1934 ext email@example.com|
|Montreal General Hospital||Recruiting|
|Montreal, Quebec, Canada, H3G 1A4|
|Principal Investigator: Stella S Daskalopoulou, MD, MSc, PhD|
|Royal Victoria Hospital||Not yet recruiting|
|Montreal, Quebec, Canada, H3A 1A1|
|Principal Investigator: Richard John Kimoff, MD, FRCP(C)|
|Principal Investigator:||Stella S Daskalopoulou, MD, MSc, PHd||McGill University Health Center|
|Principal Investigator:||R John Kimoff, MD, FRCP(C)||McGill University Health Center|