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

Primary Purpose

Obstructive Sleep Apnea, Hypertension

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
bosentan
nasal continuous positive airway pressure (CPAP)
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Cardiovascular system, Sleep, Endothelial function, Endothelin system

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU de Grenoble

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

24 hour mean diastolic blood pressure

Secondary Outcome Measures

Peripheral Arterial Tonometry measure
mean 24 hour systemic systolic blood pressure
mean 24 hour nocturnal blood pressure
carotid Intima Media Thickness
Circulating inflammation markers (RANTES, MCP-1, TNF-alpha, INF-gamma, IL-6, IL-10 and TGF-gamma
Circulating Big ET1 and ET1 levels

Full Information

First Posted
October 22, 2008
Last Updated
May 20, 2014
Sponsor
University Hospital, Grenoble
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT00777985
Brief Title
Preventive Effects of Bosentan on the Systemic Cardiovascular Consequence of Sleep Apnea
Acronym
BOSAS
Official Title
Cardiovascular Consequences of Obstructive Sleep Apnea (OSA): Role of Endothelin and Preventive Effects of Bosentan
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Actelion

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Hypertension
Keywords
Cardiovascular system, Sleep, Endothelial function, Endothelin system

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
bosentan
Other Intervention Name(s)
TRACLEER
Intervention Description
62.5 mg b.i.d for 4 weeks
Intervention Type
Device
Intervention Name(s)
nasal continuous positive airway pressure (CPAP)
Intervention Description
Daily application throughout sleep for 4 weeks
Primary Outcome Measure Information:
Title
24 hour mean diastolic blood pressure
Time Frame
before and after each treatment completion (4 weeks)
Secondary Outcome Measure Information:
Title
Peripheral Arterial Tonometry measure
Time Frame
before and after each treatment completion (4 weeks)
Title
mean 24 hour systemic systolic blood pressure
Time Frame
before and after each treatment completion (4 weeks)
Title
mean 24 hour nocturnal blood pressure
Time Frame
before and after each treatment completion (4 weeks)
Title
carotid Intima Media Thickness
Time Frame
before and after each treatment completion (4 weeks)
Title
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)
Title
Circulating Big ET1 and ET1 levels
Time Frame
before and after each treatment completion (4 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandrine H Launois, MD PhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

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

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