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Completed

NCT Number: NCT00777985

Preventive Effects of Bosentan on the Systemic Cardiovascular Consequence of Sleep Apnea

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Cardiovascular Diseases Dyssomnias Hypertension Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU de Grenoble

Grenoble, 38043, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bosentan

Drug

62.5 mg b.i.d for 4 weeks

Other names: TRACLEER

Nasal Continuous positive airway pressure (CPAP)

Device

Daily application throughout sleep for 4 weeks

Primary outcomes

  1. 24 hour mean diastolic blood pressure

    Time frame: before and after each treatment completion (4 weeks)

Secondary outcomes

  1. Peripheral Arterial Tonometry measure

    Time frame: before and after each treatment completion (4 weeks)

  2. mean 24 hour systemic systolic blood pressure

    Time frame: before and after each treatment completion (4 weeks)

  3. mean 24 hour nocturnal blood pressure

    Time frame: before and after each treatment completion (4 weeks)

  4. carotid Intima Media Thickness

    Time frame: before and after each treatment completion (4 weeks)

  5. Circulating inflammation markers (RANTES, MCP-1, TNF-alpha, INF-gamma, IL-6, IL-10 and TGF-gamma

    Time frame: before and after each treatment completion (4 weeks)

  6. Circulating Big ET1 and ET1 levels

    Time frame: before and after each treatment completion (4 weeks)

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Actelion
  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

Cardiovascular Consequences of Obstructive Sleep Apnea (OSA): Role of Endothelin and Preventive Effects of Bosentan

Acronym: BOSAS

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Oct 23, 2008
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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