Russian Study of the Effect of Continuous Positive Airway Pressure (CPAP) in Hypertension

Study Overview
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Brief Summary
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The purpose of this study is to determine whether CPAP is effective in the treatment of systemic hypertension.

Detailed Description
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It is now well known that cardiovascular risks are increased in patients with obstructive sleep apnea syndrome (OSAS). Also a link has already been demonstrated between OSAS and hypertension. Nowadays, the most efficient treatment of the OSAS is the continuous Positive Airway Pressure (cPAP). Several studies have also shown that cPAP could reduce arterial blood pressure in OSAS patients. But level of blood pressure (BP), drug treatment were not equal between groups and it's difficult to single out independent role of cPAP. Our study has the objective to compare the effects of cPAP on hypertension in OSAS patients. After 3-9 weeks of antihypertensive treatment (valsartan and amlodipine) those one who reached target level of BP will be randomized either in the group treatment by cPAP or in the group treatment by cham-cPAP for 3 weeks and then we'll perform cross-over.

Official Title
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Study of Independent Role of Continuous Positive Airway Pressure Therapy on Systemic Arterial Pressure in Patients With Sleep Apnea Syndrome and Arterial Hypertension

Conditions
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Obstructive Sleep Apnea Syndrome, Hypertension

Intervention / Treatment
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* Procedure: cPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male/female over than 18 years old patient with an obstructive sleep apnea (apnea-hypopnea index > or equal to 15) patient with weak or moderate hypertension (140 <= SBP < 180 mmHg and 90 <= DBP < 110 mmHg) negative pregnancy test ambulatory patient patient who have signed the informed consent form Exclusion Criteria: pregnant or nursing woman woman who refuses to use contraceptive method acute hepatic failure, biliary cirrhosis, cholestasis clearance of Cockcroft < 30 ml/min/1.73m2 kaliemia >= 5.5 mmol/l acute hypertension (SBP>= 180 mmHg and/or DBP >= 110 mmHg) acute daytime sleepiness (Epworth rating scale > 15) patient with a profession that is inconsistent with the continuous positive airway pressure (CPAP) treatment known cardiovascular pathologies contraindication to CPAP allergy to valsartan and/or amlodipine patient treated with lithium patient on tutelle or curatelle patient kept in detention, major protected by the law, hospitalized person patient currently participating in another clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Procedure: cPAP<br>* After reaching target level of BP patients will be randomized in active group (cPAP) and control group (sham-cPAP)<br>|
| Sham Comparator: 2<br> | Procedure: cPAP<br>* After reaching target level of BP patients will be randomized in active group (cPAP) and control group (sham-cPAP)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulatory blood pressure monitoring over 24 hours, at inclusion visit (day=0), before cPAP (3-9 weeks) and after 3 weeks of cPAP. |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea, obstructive sleep apnea syndrome, hypertension, systemic hypertension, ambulatory blood pressure monitoring