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

Primary Purpose

Hypertension, Endothelial Dysfunction, Obstructive Sleep Apnea

Status
Unknown status
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Nebivolol
Continuous positive airway pressure (CPAP)
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Nebivolol then CPAP

CPAP then Nebivolol

Arm Description

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

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

Outcomes

Primary Outcome Measures

change in mean arterial blood pressure

Secondary Outcome Measures

change in endothelial function

Full Information

First Posted
September 5, 2012
Last Updated
January 15, 2013
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01771406
Brief Title
CPAP and Nebivolol in Hypertensive Obstructive Sleep Apnea (OSA) Patients.
Acronym
NEBOSA
Official Title
Effects of Continuous Positive Airway Pressure (CPAP) and Nebivolol Treatment on Arterial Blood Pressure and Endothelial Function in Hypertensive OSA Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Endothelial Dysfunction, Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nebivolol then CPAP
Arm Type
Experimental
Arm Description
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
Arm Title
CPAP then Nebivolol
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Nebivolol
Intervention Description
8 weeks of Nebivolol treatment (5mg/day)
Intervention Type
Device
Intervention Name(s)
Continuous positive airway pressure (CPAP)
Other Intervention Name(s)
Philips Respironics Remstar System One
Intervention Description
8 weeks of CPAP treatment
Primary Outcome Measure Information:
Title
change in mean arterial blood pressure
Time Frame
measurement assessed at w8,w14,w22
Secondary Outcome Measure Information:
Title
change in endothelial function
Time Frame
measurement assessed at w8,w14,w22

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catharina Belge, M.D., Ph. D.
Phone
+3216342520
Email
secretariaat.slaaplabo@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catharina Belge, M.D., Ph.D.
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catharina Belge, M.D., Ph.D.
Phone
+3216342520

12. IPD Sharing Statement

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

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