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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2012 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01771406
First received: September 5, 2012
Last updated: January 15, 2013
Last verified: August 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in endothelial function [ Time Frame: measurement assessed at w8,w14,w22 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771406

Contacts
Contact: Catharina Belge, M.D., Ph. D. +3216342520 secretariaat.slaaplabo@uzleuven.be

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

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01771406     History of Changes
Other Study ID Numbers: S54613
Study First Received: September 5, 2012
Last Updated: January 15, 2013
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Apnea
Hypertension
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Nebivolol
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014