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
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | January 6, 2010 | ||||||||
| Last Updated Date | January 6, 2010 | ||||||||
| Start Date ICMJE | December 2009 | ||||||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
24 hour blood pressure. [ Time Frame: 6 weeks and 12 weeks after initial intervention ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect of Continuous Positive Airway Pressure (CPAP) Versus Auto-titrating Continuous Positive Airway Pressure (APAP) on Resistant Hypertension (HTN) and Arterial Stiffness | ||||||||
| Official Title ICMJE | 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 | ||||||||
| Brief Summary | 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. |
||||||||
| Detailed Description | 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 ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE |
|
||||||||
| Study Arm (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 34 | ||||||||
| Estimated Completion Date | January 2011 | ||||||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01044355 | ||||||||
| Other Study ID Numbers ICMJE | 09-038-SDR (SARHT 1001) | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Dr. Stella Daskalopoulou, McGill University Health Center | ||||||||
| Study Sponsor ICMJE | McGill University Health Center | ||||||||
| Collaborators ICMJE | OSR Medical Inc. | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | McGill University Health Center | ||||||||
| Verification Date | January 2010 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||