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

Hypertension Clinical Trial

— NEBOSA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01771406
• Other study ID #: S54613
• Status: Not yet recruiting
• Phase: Phase 4
• First received: September 5, 2012
• Last updated: January 15, 2013
• Start date: February 2013
• Est. completion date: February 2016

Study information

• Verified date: August 2012
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Catharina Belge, M.D., Ph. D.
• Phone: +3216342520
• Email: secretariaat.slaaplabo[@]uzleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Hypertension
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Nebivolol
8 weeks of Nebivolol treatment (5mg/day)

Device:
• Continuous positive airway pressure (CPAP)
8 weeks of CPAP treatment

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in mean arterial blood pressure		measurement assessed at w8,w14,w22	No
Secondary	change in endothelial function		measurement assessed at w8,w14,w22	No