Preventive Effects of Bosentan on the Systemic Cardiovascular Consequence of Sleep Apnea (NCT00777985) | Clinical Trial Compass
CompletedPhase 2
Preventive Effects of Bosentan on the Systemic Cardiovascular Consequence of Sleep Apnea
France19 participantsStarted 2007-12
Plain-language summary
The study will compared the effects of bosentan, an endothelin receptor antagonist, and nasal continuous positive airway pressure (nCPAP), obstructive sleep apnea current reference treatment, on diastolic blood pressure in untreated mildly hypertensive sleep apnea patients.
The hypothesis is that blocking endothelin receptors with a drug will have the same systemic blood pressure lowering effect than nCPAP in sleep apnea patients.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Documented obstructive sleep apnea
* with untreated mild systemic hypertension
Exclusion Criteria:
* pregnancy or lactation
* daytime alveolar hypoventilation
* severe arterial hypertension (systolic pressure \> 180 mmHg; diastolic pressure \> 110 mmHg)
* treatment with anti-hypertensive drugs
* cardiovascular disorder other than mild hypertension
* severe daytime sleepiness (score on the EPWORTH sleepiness scale ≥15) or at-risk occupation
* contra-indication to nCPAP treatment
* known allergy to bosentan
* active treatment with a drug whose efficacy is reduced by cytochromes P450, 2C9, 3A4 and2C19 isoenzyme activation
* active treatment with a drug acting on systemic arterial blood pressure or endothelial function
* liver or kidney dysfunction
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
24 hour mean diastolic blood pressure
Timeframe: before and after each treatment completion (4 weeks)