NCT00777985

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

4.1 years

First QC Date

October 22, 2008

Last Update Submit

December 15, 2025

Conditions

Obstructive Sleep ApneaHypertension

Keywords

Cardiovascular systemSleepEndothelial functionEndothelin system

Outcome Measures

Primary Outcomes (1)

  • 24 hour mean diastolic blood pressure

    before and after each treatment completion (4 weeks)

Secondary Outcomes (6)

  • Peripheral Arterial Tonometry measure

    before and after each treatment completion (4 weeks)

  • 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)

  • carotid Intima Media Thickness

    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)

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Drug: bosentan

2

ACTIVE COMPARATOR
Device: nasal continuous positive airway pressure (CPAP)

Interventions

bosentanDRUG

62.5 mg b.i.d for 4 weeks

Also known as: TRACLEER
1
nasal continuous positive airway pressure (CPAP)DEVICE

Daily application throughout sleep for 4 weeks

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented obstructive sleep apnea
  • with untreated mild systemic hypertension

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Grenoble

Grenoble, 38043, France

Location

Related Publications (1)

  • 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.

    PMID: 26643404RESULT

MeSH Terms

Conditions

Sleep Apnea, ObstructiveHypertension

Interventions

BosentanContinuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPositive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Sandrine H Launois, MD PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2008

First Posted

October 23, 2008

Study Start

December 1, 2007

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations

FR(1)