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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 2013
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. change in mean arterial blood pressure [ Time Frame: measurement assessed at w8,w14,w22 ]

Secondary Outcome Measures :
  1. change in endothelial function [ Time Frame: measurement assessed at w8,w14,w22 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771406


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

Locations
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Belgium
University Hospitals Leuven
Leuven, Belgium, 3000
Contact: Catharina Belge, M.D., Ph.D.    +3216342520      
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Catharina Belge, M.D., Ph.D. Universitaire Ziekenhuizen Leuven
More Information
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01771406    
Other Study ID Numbers: S54613
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: January 18, 2013
Last Verified: August 2012
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Nebivolol
 Antihypertensive Agents
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs