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

Universitaire Ziekenhuizen KU Leuven

Status and phase: Unknown; Phase 4

Conditions: Hypertension; Endothelial Dysfunction; Obstructive Sleep Apnea

Treatments: Drug: Nebivolol; Device: Continuous positive airway pressure (CPAP)

Study type: Interventional

Funder types: Other

Identifiers

NCT01771406

S54613

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Nebivolol then CPAP

Experimental group

Description:

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

Treatment:

Device: Continuous positive airway pressure (CPAP)

Drug: Nebivolol

CPAP then Nebivolol

Experimental group

Description:

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

Treatment:

Device: Continuous positive airway pressure (CPAP)

Drug: Nebivolol