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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01771406

Acronym

NEBOSA

Enrollment

Registered

2013-01-18

Start date

2013-02-28

Completion date

2016-02-29

Last updated

2013-01-18

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

Conditions

Endothelial Dysfunction, Hypertension, Obstructive Sleep Apnea

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.

Interventions

DRUGNebivolol

8 weeks of Nebivolol treatment (5mg/day)

DEVICEContinuous positive airway pressure (CPAP)

8 weeks of CPAP treatment

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
change in mean arterial blood pressure	measurement assessed at w8,w14,w22

Secondary

Measure	Time frame
change in endothelial function	measurement assessed at w8,w14,w22

Countries

Belgium

Contacts

Primary ContactCatharina Belge, M.D., Ph. D.

secretariaat.slaaplabo@uzleuven.be+3216342520

Outcome results

None listed

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