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

• ClinicalTrials.gov Identifier: NCT01771406
• Recruitment Status: Unknown
• First Posted: January 18, 2013
• Last Update Posted: January 18, 2013
• Sponsor: Universitaire Ziekenhuizen Leuven
• Information provided by (Responsible Party): Universitaire Ziekenhuizen Leuven

Tracking Information

• First Submitted Date: September 5, 2012
• First Posted Date: January 18, 2013
• Last Update Posted Date: January 18, 2013
• Study Start Date: February 2013
• Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 15, 2013): change in mean arterial blood pressure [ Time Frame: measurement assessed at w8,w14,w22 ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: January 15, 2013): change in endothelial function [ Time Frame: measurement assessed at w8,w14,w22 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: CPAP and Nebivolol in Hypertensive Obstructive Sleep Apnea (OSA) Patients.
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Hypertension
• Endothelial Dysfunction
• Obstructive Sleep Apnea

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 15, 2013): 36
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 2016
• Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT01771406
• Other Study ID Numbers: S54613
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Universitaire Ziekenhuizen Leuven
• Study Sponsor: Universitaire Ziekenhuizen Leuven
• Collaborators: Not Provided

Investigators

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

• PRS Account: Universitaire Ziekenhuizen Leuven
• Verification Date: August 2012