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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven Identifier:
First received: September 5, 2012
Last updated: January 15, 2013
Last verified: August 2012
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.

Condition Intervention Phase
Endothelial Dysfunction
Obstructive Sleep Apnea
Drug: Nebivolol
Device: Continuous positive airway pressure (CPAP)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Continuous Positive Airway Pressure (CPAP) and Nebivolol Treatment on Arterial Blood Pressure and Endothelial Function in Hypertensive OSA Patients.

Resource links provided by NLM:

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • change in mean arterial blood pressure [ Time Frame: measurement assessed at w8,w14,w22 ]

Secondary Outcome Measures:
  • change in endothelial function [ Time Frame: measurement assessed at w8,w14,w22 ]

Estimated Enrollment: 36
Study Start Date: February 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nebivolol then 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
Drug: Nebivolol
8 weeks of Nebivolol treatment (5mg/day)
Device: Continuous positive airway pressure (CPAP)
8 weeks of CPAP treatment
Other Name: Philips Respironics Remstar System One
Experimental: CPAP then 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
Drug: Nebivolol
8 weeks of Nebivolol treatment (5mg/day)
Device: Continuous positive airway pressure (CPAP)
8 weeks of CPAP treatment
Other Name: Philips Respironics Remstar System One


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01771406

Contact: Catharina Belge, M.D., Ph. D. +3216342520

University Hospitals Leuven Not yet recruiting
Leuven, Belgium, 3000
Contact: Catharina Belge, M.D., Ph.D.    +3216342520      
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Principal Investigator: Catharina Belge, M.D., Ph.D. University Hospitals, Leuven
  More Information

Responsible Party: Universitaire Ziekenhuizen Leuven Identifier: NCT01771406     History of Changes
Other Study ID Numbers: S54613
Study First Received: September 5, 2012
Last Updated: January 15, 2013

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Antihypertensive Agents
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 25, 2017