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

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ClinicalTrials.gov Identifier: NCT01771406
Recruitment Status : Unknown
Verified August 2012 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Not yet recruiting
First Posted : January 18, 2013
Last Update Posted : January 18, 2013
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Tracking Information
First Submitted Date  ICMJE September 5, 2012
First Posted Date  ICMJE January 18, 2013
Last Update Posted Date January 18, 2013
Study Start Date  ICMJE February 2013
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2013)
change in mean arterial blood pressure [ Time Frame: measurement assessed at w8,w14,w22 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2013)
change in endothelial function [ Time Frame: measurement assessed at w8,w14,w22 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CPAP and Nebivolol in Hypertensive Obstructive Sleep Apnea (OSA) Patients.
Official Title  ICMJE Effects of Continuous Positive Airway Pressure (CPAP) and Nebivolol Treatment on Arterial Blood Pressure and Endothelial Function in Hypertensive OSA Patients.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Endothelial Dysfunction
  • Obstructive Sleep Apnea
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Nebivolol
    • Device: Continuous positive airway pressure (CPAP)
  • 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
    Interventions:
    • Drug: Nebivolol
    • Device: Continuous positive airway pressure (CPAP)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 15, 2013)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2016
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01771406
Other Study ID Numbers  ICMJE S54613
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Universitaire Ziekenhuizen Leuven
Study Sponsor  ICMJE Universitaire Ziekenhuizen Leuven
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Catharina Belge, M.D., Ph.D. Universitaire Ziekenhuizen Leuven
PRS Account Universitaire Ziekenhuizen Leuven
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP