Effect of Continuous Positive Airway Pressure (CPAP) Versus Auto-titrating Continuous Positive Airway Pressure (APAP) on Resistant Hypertension (HTN) and Arterial Stiffness
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01044355|
Recruitment Status : Active, not recruiting
First Posted : January 7, 2010
Last Update Posted : March 22, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Resistant Hypertension Obstructive Sleep Apnea||Device: CPAP Device: APAP||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||January 2020|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|