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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00801671

Enrollment

Registered

2008-12-03

Start date

2008-09-30

Completion date

2011-06-30

Last updated

2011-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Obstructive Sleep Apnea Syndrome

Keywords

obstructive sleep apnea, obstructive sleep apnea syndrome, hypertension, systemic hypertension, ambulatory blood pressure monitoring

Brief summary

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

Detailed description

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.

Interventions

PROCEDUREcPAP

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026