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

Phase 4

• Conditions: Hypertension; Endothelial Dysfunction; Obstructive Sleep Apnea
• Interventions: Drug: Nebivolol; Device: Continuous positive airway pressure (CPAP)

• Registration Number: NCT01771406
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-08
• Study First Submitted: 2012-09-05
• Study First Submitted QC: 2013-01-15
• Last Update Submitted: 2013-01-15
• Study First Posted: 2013-01-18
• Last Update Posted: 2013-01-18
• Study Start: 2013-02
• Primary Completion: 2016-02
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nebivolol then CPAP	Nebivolol	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
Nebivolol then CPAP	Continuous positive airway pressure (CPAP)	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
CPAP then Nebivolol	Continuous positive airway pressure (CPAP)	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
CPAP then Nebivolol	Nebivolol	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

Primary Outcome Measures

Name	Time	Method
change in mean arterial blood pressure	measurement assessed at w8,w14,w22

Secondary Outcome Measures

Name	Time	Method
change in endothelial function	measurement assessed at w8,w14,w22

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium