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| Name | Class |
|---|---|
| OSR Medical Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| auto-titrating | Active Comparator | Patients being treated for 6 weeks with auto-titrating continuous airway pressure. |
|
| Fixed | Active Comparator | Patients receiving 6 weeks of treatment with fixed continuous positive airway pressure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP | Device | 6 weeks treatment with fixed CPAP |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 24 hour blood pressure. | 6 weeks and 12 weeks after initial intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Non-invasive measures of arterial stiffness using applanation tonometry. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stella S Daskalopoulou, MD, MSc, PHd | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| R John Kimoff, MD, FRCP(C) | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Victoria Hospital | Montreal | Quebec | H3A 1A1 | Canada | ||
| Montreal General Hospital |
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| APAP | Device | 6 weeks of treatment with auto-titrating positive airway pressure |
|
|
| 6 weeks and 12 weeks after initial intervention |
| Blood tests to assess levels of aldosterone, hsCRP, fasting glucose, HbA1c, and plasma insulin. | 6 weeks and 12 weeks after initial intervention |
| Montreal |
| Quebec |
| H3G 1A4 |
| Canada |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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