Hypertension, Obstructive Sleep Apnea
Conditions
Keywords
Cardiovascular system, Sleep, Endothelial function, Endothelin system
Brief 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.
Interventions
DRUGbosentan
62.5 mg b.i.d for 4 weeks
Daily application throughout sleep for 4 weeks
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Actelion
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24 hour mean diastolic blood pressure | before and after each treatment completion (4 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| mean 24 hour systemic systolic blood pressure | before and after each treatment completion (4 weeks) |
| mean 24 hour nocturnal blood pressure | before and after each treatment completion (4 weeks) |
| Peripheral Arterial Tonometry measure | before and after each treatment completion (4 weeks) |
| Circulating inflammation markers (RANTES, MCP-1, TNF-alpha, INF-gamma, IL-6, IL-10 and TGF-gamma | before and after each treatment completion (4 weeks) |
| Circulating Big ET1 and ET1 levels | before and after each treatment completion (4 weeks) |
| carotid Intima Media Thickness | before and after each treatment completion (4 weeks) |
Countries
France
Outcome results
None listed