HypertensionPhase 4NEBOSANCT01771406
CPAP and Nebivolol in Hypertensive Obstructive Sleep Apnea (OSA) Patients.
A Phase 4 study testing Nebivolol and Continuous positive airway pressure (CPAP) in people with Hypertension and Endothelial Dysfunction, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Endothelial Dysfunction, Obstructive Sleep Apnea
- What is being tested?
- Nebivolol and Continuous positive airway pressure (CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2013to Feb 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
University Hospitals Leuven
Leuven, 3000
Catharina Belge, M.D., Ph.D., +3216342520
About this study
Official title: Effects of Continuous Positive Airway Pressure (CPAP) and Nebivolol Treatment on Arterial Blood Pressure and Endothelial Function in Hypertensive OSA Patients.
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.
- Being tested
- Nebivolol, Continuous positive airway pressure (CPAP)
- Medical subject headings
- Hypertension, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NebivololDrug
8 weeks of Nebivolol treatment (5mg/day)
Continuous positive airway pressure (CPAP)Device
Also called Philips Respironics Remstar System One
8 weeks of CPAP treatment
| Study group | Role | What they receive |
|---|---|---|
| Nebivolol then CPAP | Experimental | 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 Receives: Drug: Nebivolol; Device: Continuous positive airway pressure (CPAP) |
| CPAP then Nebivolol | Experimental | 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 Receives: Drug: Nebivolol; Device: Continuous positive airway pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in mean arterial blood pressure
Measured: measurement assessed at w8,w14,w22
Secondary outcomes (1)
change in endothelial function
Measured: measurement assessed at w8,w14,w22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catharina Belge, M.D., Ph.D., Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771406
- Sponsor's protocol ID
- S54613
- Acronym
- NEBOSA
- Status last verified
- Aug 2012
- First submitted
- 5 Sep 2012
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Continuous Positive Airway Pressure (CPAP) and Nebivolol Treatment on Arterial Blood Pressure and Endothelial Function in Hypertensive OSA Patients.
- ClinicalTrials.gov ID
- NCT01771406
- Acronym / sponsor ID
- NEBOSA / S54613
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 18 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebivolol then CPAP | Experimental | Drug: Nebivolol, Device: Continuous positive airway pressure (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 |
| CPAP then Nebivolol | Experimental | Drug: Nebivolol, Device: Continuous positive airway pressure (CPAP)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nebivolol8 weeks of Nebivolol treatment (5mg/day) | Drug | CPAP then Nebivolol, Nebivolol then CPAP |
| Continuous positive airway pressure (CPAP)Also: Philips Respironics Remstar System One8 weeks of CPAP treatment | Device | CPAP then Nebivolol, Nebivolol then CPAP |
Primary outcome
change in mean arterial blood pressure
Time frame: measurement assessed at w8,w14,w22
1 secondary outcome
change in endothelial function
Time frame: measurement assessed at w8,w14,w22
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catharina Belge, M.D., Ph.D. principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nebivolol and Continuous positive airway pressure (CPAP) in people with Hypertension and Endothelial Dysfunction, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catharina Belge, M.D., Ph. D. (+3216342520, secretariaat.slaaplabo@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in mean arterial blood pressure (time frame: measurement assessed at w8,w14,w22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2013.