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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-06-30

Brief Summary

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

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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.

Conditions

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Obstructive Sleep Apnea Syndrome Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type ACTIVE_COMPARATOR

cPAP

Intervention Type PROCEDURE

After reaching target level of BP patients will be randomized in active group (cPAP) and control group (sham-cPAP)

2

Group Type SHAM_COMPARATOR

cPAP

Intervention Type PROCEDURE

After reaching target level of BP patients will be randomized in active group (cPAP) and control group (sham-cPAP)

Interventions

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cPAP

After reaching target level of BP patients will be randomized in active group (cPAP) and control group (sham-cPAP)

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No