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

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Unknown status
CT.gov ID
NCT01771406
Collaborator
(none)
36
Enrollment
1
Location
2
Arms
36
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (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.
Study Start Date :
Feb 1, 2013
Anticipated Primary Completion Date :
Feb 1, 2016
Anticipated Study Completion Date :
Feb 1, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. change in mean arterial blood pressure [measurement assessed at w8,w14,w22]

    Secondary Outcome Measures

    1. change in endothelial function [measurement assessed at w8,w14,w22]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Locations

    Site City State Country Postal Code
    1 University Hospitals Leuven Leuven Belgium 3000

    Sponsors and Collaborators

    • Universitaire Ziekenhuizen Leuven

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitaire Ziekenhuizen Leuven
    ClinicalTrials.gov Identifier:
    NCT01771406
    Other Study ID Numbers:
    • S54613
    First Posted:
    Jan 18, 2013
    Last Update Posted:
    Jan 18, 2013
    Last Verified:
    Aug 1, 2012
    Additional relevant MeSH terms:
    Sleep Apnea Syndromes
    Sleep Apnea, Obstructive
    Nebivolol

    Study Results

    No Results Posted as of Jan 18, 2013