CPAP and Nebivolol in Hypertensive Obstructive Sleep Apnea (OSA) Patients.

Study Overview
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Brief Summary
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The aim of this study is to examine how effective CPAP treatment and treatment with nebivolol are respectively on reducing blood pressure and on endothelial dysfunction in patients suffering from obstructive sleep apnea and hypertension.

Official Title
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Effects of Continuous Positive Airway Pressure (CPAP) and Nebivolol Treatment on Arterial Blood Pressure and Endothelial Function in Hypertensive OSA Patients.

Conditions
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Hypertension, Endothelial Dysfunction, Obstructive Sleep Apnea

Intervention / Treatment
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* Drug: Nebivolol
* Device: Continuous positive airway pressure (CPAP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male/female ≥ 18 years old patient with obstructive sleep apnea (apnea-hypopnea index ≥ 20) naïve for CPAP treatment patient with weak or moderate hypertension (140 <= systolic blood pressure (SBP) < 180 mmHg and 90 <= diastolic blood pressure (DBP) < 110 mmHg naïve for any antihypertensive treatment negative pregnancy test ambulatory patient patient who have signed the informed consent form patient affiliated to social security Exclusion Criteria: pregnant or nursing woman acute hepatic failure, biliary cirrhosis, cholestasis clearance of Cockcroft < 30 ml/min/1.73m2 sick sinus syndrome, including sino-atrial block second and third degree heart block (without a pacemaker) history of bronchospasm and bronchial asthma bradycardia (heart rate< 60bpm prior to start therapy) severe peripheral circulatory disturbances acute hypertension (SBP>= 180 mmHg and/or DBP >= 110 mmHg) severe daytime sleepiness (Epworth rating scale > 15) known cardiovascular pathologies contraindication to CPAP allergy to nebivolol patient treated with antihypertensive drug(s), with class I antiarrhythmics (quinidine, hydroquinidine, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone) patient treated with CPAP patient kept in detention, major protected by the law, hospitalised person patient currently participating in another clinical trial

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nebivolol then CPAP<br>8 weeks of Nebivolol treatment (5m/day), 6 weeks of washout, 8 weeks of CPAP and if the patient is still hypertensive 8 weeks of Nebivolol plus CPAP treatment | Drug: Nebivolol<br>* 8 weeks of Nebivolol treatment (5mg/day)<br>Device: Continuous positive airway pressure (CPAP)<br>* 8 weeks of CPAP treatment<br>* Other names: Philips Respironics Remstar System One;|
| Experimental: CPAP then Nebivolol<br>8 weeks of CPAP treatment, 6 weeks of washout, 8 weeks of Nebivolol and if the patient is still hypertensive 8 weeks of Nebivolol plus CPAP treatment | Drug: Nebivolol<br>* 8 weeks of Nebivolol treatment (5mg/day)<br>Device: Continuous positive airway pressure (CPAP)<br>* 8 weeks of CPAP treatment<br>* Other names: Philips Respironics Remstar System One;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in mean arterial blood pressure |  | measurement assessed at w8,w14,w22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in endothelial function |  | measurement assessed at w8,w14,w22 |