Obstructive Sleep ApneaPhase 2BOSASNCT00777985
Preventive Effects of Bosentan on the Systemic Cardiovascular Consequence of Sleep Apnea
A Phase 2 study testing bosentan and nasal continuous positive airway pressure (CPAP) in people with Obstructive Sleep Apnea and Hypertension, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea, Hypertension
- What is being tested?
- bosentan and nasal continuous positive airway pressure (CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2007to Jan 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented obstructive sleep apnea
- with untreated mild systemic hypertension
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular Consequences of Obstructive Sleep Apnea (OSA): Role of Endothelin and Preventive Effects of Bosentan
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.
- Conditions
- Obstructive Sleep Apnea, Hypertension
- Being tested
- bosentan, nasal continuous positive airway pressure (CPAP)
- Keywords
- Cardiovascular system, Sleep, Endothelial function, Endothelin system
- Medical subject headings
- Sleep Apnea, Obstructive, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bosentanDrug
Also called TRACLEER
62.5 mg b.i.d for 4 weeks
nasal continuous positive airway pressure (CPAP)Device
Daily application throughout sleep for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: bosentan |
| 2 | Active comparator | Not described Receives: Device: nasal continuous positive airway pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour mean diastolic blood pressure
Measured: before and after each treatment completion (4 weeks)
Secondary outcomes (6)
Peripheral Arterial Tonometry measure
Measured: before and after each treatment completion (4 weeks)
mean 24 hour systemic systolic blood pressure
Measured: before and after each treatment completion (4 weeks)
mean 24 hour nocturnal blood pressure
Measured: before and after each treatment completion (4 weeks)
carotid Intima Media Thickness
Measured: 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
Measured: before and after each treatment completion (4 weeks)
Circulating Big ET1 and ET1 levels
Measured: before and after each treatment completion (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2008 (estimated)
- Study startDec 2007
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Actelion
- Responsible party
- Sponsor
- Investigators
- Sandrine H Launois, MD PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777985
- Sponsor's protocol ID
- 0722
- Other IDs
- 2007-005333-11
- Acronym
- BOSAS
- Status last verified
- Dec 2025
- First submitted
- 22 Oct 2008
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Joyeux-Faure M, Jullian-Desayes I, Pepin JL, Cracowski JL, Baguet JP, Tamisier R, Levy P, Godin-Ribuot D, Launois SH. Comparison of continuous positive airway pressure and bosentan effect in mildly hypertensive patients with obstructive sleep apnoea: A randomized controlled pilot study. Respirology. 2016 Apr;21(3):546-52. doi: 10.1111/resp.12713. Epub 2015 Dec 8.
PubMed 26643404
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Consequences of Obstructive Sleep Apnea (OSA): Role of Endothelin and Preventive Effects of Bosentan
- ClinicalTrials.gov ID
- NCT00777985
- Acronym / sponsor ID
- BOSAS / 0722
- Conditions
- Obstructive Sleep Apnea, Hypertension
- Keywords
- Cardiovascular system, Sleep, Endothelial function, Endothelin system
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Actelion
- Study start
- Dec 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 23 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: bosentan |
| 2 | Active comparator | Device: nasal continuous positive airway pressure (CPAP) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Documented obstructive sleep apnea
- with untreated mild systemic hypertension
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bosentanAlso: TRACLEER62.5 mg b.i.d for 4 weeks | Drug | 1 |
| nasal continuous positive airway pressure (CPAP)Daily application throughout sleep for 4 weeks | Device | 2 |
Primary outcome
24 hour mean diastolic blood pressure
Time frame: before and after each treatment completion (4 weeks)
6 secondary outcomes
Peripheral Arterial Tonometry measure
Time frame: before and after each treatment completion (4 weeks)
mean 24 hour systemic systolic blood pressure
Time frame: before and after each treatment completion (4 weeks)
mean 24 hour nocturnal blood pressure
Time frame: before and after each treatment completion (4 weeks)
carotid Intima Media Thickness
Time frame: 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
Time frame: before and after each treatment completion (4 weeks)
Circulating Big ET1 and ET1 levels
Time frame: before and after each treatment completion (4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 26643404Joyeux-Faure M, Jullian-Desayes I, Pepin JL, Cracowski JL, Baguet JP, Tamisier R, Levy P, Godin-Ribuot D, Launois SH. Comparison of continuous positive airway pressure and bosentan effect in mildly hypertensive patients with obstructive sleep apnoea: A randomized controlled pilot study. Respirology. 2016 Apr;21(3):546-52. doi: 10.1111/resp.12713. Epub 2015 Dec 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandrine H Launois, MD PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bosentan and nasal continuous positive airway pressure (CPAP) in people with Obstructive Sleep Apnea and Hypertension, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hour mean diastolic blood pressure (time frame: before and after each treatment completion (4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00777985, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.