Preventive Effects of Bosentan on the Systemic Cardiovascular Consequence of Sleep Apnea (BOSAS)

Grenoble Alpes University Hospital Center (CHU)

Status and phase

Completed

Phase 2

Conditions

Hypertension

Obstructive Sleep Apnea

Treatments

Device: nasal continuous positive airway pressure (CPAP)

Drug: bosentan

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00777985

2007-005333-11 (Registry Identifier)

0722

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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