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

January 15, 2013 updated by: Universitaire Ziekenhuizen KU Leuven

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • University Hospitals Leuven
        • Contact:
          • Catharina Belge, M.D., Ph.D.
          • Phone Number: +3216342520

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Philips Respironics Remstar System One

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in mean arterial blood pressure
Time Frame: measurement assessed at w8,w14,w22
measurement assessed at w8,w14,w22

Secondary Outcome Measures

Outcome Measure
Time Frame
change in endothelial function
Time Frame: measurement assessed at w8,w14,w22
measurement assessed at w8,w14,w22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Catharina Belge, M.D., Ph.D., Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

September 5, 2012

First Submitted That Met QC Criteria

January 15, 2013

First Posted (Estimate)

January 18, 2013

Study Record Updates

Last Update Posted (Estimate)

January 18, 2013

Last Update Submitted That Met QC Criteria

January 15, 2013

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S54613

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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