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
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 ]
- 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 ]
|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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044355
|Royal Victoria Hospital|
|Montreal, Quebec, Canada, H3A 1A1|
|Montreal General Hospital|
|Montreal, Quebec, Canada, H3G 1A4|
|Principal Investigator:||Stella S Daskalopoulou, MD, MSc, PHd||McGill University Health Center|
|Principal Investigator:||R John Kimoff, MD, FRCP(C)||McGill University Health Center|