Russian Study of the Effect of Continuo… | Clinical Trial

Key information

Conditions

Obstructive Sleep Apnea Syndrome Apnea Cardiovascular Diseases Dyssomnias Hypertension Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Russian Cardiologe Research and Production Complex

Moscow, 121552, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cPAP

Procedure

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

Primary outcomes

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

Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Russian Cardiology Research and Production Center

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Dec 3, 2008
Registry last updated: Jun 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed