CPAP and Nebivolol in Hypertensive Obstructive Sleep Apnea (OSA) Patients.
NCT ID: NCT01771406
Last Updated: 2013-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
36 participants
INTERVENTIONAL
2013-02-28
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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
Nebivolol
8 weeks of Nebivolol treatment (5mg/day)
Continuous positive airway pressure (CPAP)
8 weeks of CPAP treatment
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
Nebivolol
8 weeks of Nebivolol treatment (5mg/day)
Continuous positive airway pressure (CPAP)
8 weeks of CPAP treatment
Interventions
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Nebivolol
8 weeks of Nebivolol treatment (5mg/day)
Continuous positive airway pressure (CPAP)
8 weeks of CPAP treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Catharina Belge, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Locations
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University Hospitals Leuven
Leuven, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Catharina Belge, M.D., Ph.D.
Role: primary
Other Identifiers
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S54613
Identifier Type: -
Identifier Source: org_study_id
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