Trials / Unknown
UnknownNCT01044355
Effect of Continuous Positive Airway Pressure (CPAP) Versus Auto-titrating Continuous Positive Airway Pressure (APAP) on Resistant Hypertension (HTN) and Arterial Stiffness
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CPAP | 6 weeks treatment with fixed CPAP |
| DEVICE | APAP | 6 weeks of treatment with auto-titrating positive airway pressure |
Timeline
- Start date
- 2009-12-01
- Primary completion
- 2014-01-01
- Completion
- 2020-01-01
- First posted
- 2010-01-07
- Last updated
- 2018-03-22
Locations
2 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT01044355. Inclusion in this directory is not an endorsement.