NCT00646971

Brief Summary

Patients with sleep apnea syndrome have repeated apneic events that induce periodic hypoxia-reoxygenation, drawing away an overproduction of oxidants. This exaggerated generation of oxidants is associated with a dysfunction of the vascular endothelium that evolves, in its turn, towards cardiovascular diseases such as systemic hypertension, stroke, and myocardial infarction. The major aim of our study is to examine the effect of CPAP treatment on biochemical (markers of oxidative stress) and functional (endothelium-dependent vascular relaxation reactivity) abnormalities at 1 and 4 weeks of treatment.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 31, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

July 12, 2010

Status Verified

May 1, 2010

Enrollment Period

2.2 years

First QC Date

March 17, 2008

Last Update Submit

July 9, 2010

Conditions

Obstructive Sleep Apnea SyndromeEndothelial DysfunctionOxidative StressIntermittent HypoxiaCardiovascular Risk

Keywords

IsoprostaneAlkaneExhaled condensatePeripheral arterial tonometryPolysomnographyObstructive Sleep ApneaHypoxia

Outcome Measures

Primary Outcomes (1)

  • To examine the effect of CPAP treatment on biochemical (markers of oxidative stress) abnormalities

    1 and 4 weeks of treatment

Secondary Outcomes (4)

  • To compare between patients with severe OSAS and controls, the degree of the production of markers of oxidative stress non-invasively measured in both the exhaled gas and urine samples

    before and after a nocturnal polysomnography

  • To compare between patients and controls, the endothelium-dependent vascular relaxation

    before and after nocturnal polysomnography

  • To analyze the relationship between these biochemical and functional abnormalities and the standard criteria of severity of OSAS.

    before and after nocturnal polysomnography

  • To examine the effect of CPAP treatment on functional (endothelium-dependent vascular relaxation reactivity) abnormalities

    1 and 4 weeks of treatment

Study Arms (2)

1

EXPERIMENTAL

CPAP

Device: CPAP device

2

SHAM COMPARATOR

sham CPAP

Device: Placebo device

Interventions

CPAP deviceDEVICE

for 4 weeks

Also known as: CPAP
1
Placebo deviceDEVICE

for 4 weeks

Also known as: Placebo
2

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No smoking
  • years old subjects
  • being referred for daytime hyper- somnolence and snoring
  • apnea hypopnea index \>=30/hour and desaturation index\>=30/hour

You may not qualify if:

  • Chronic lung diseases.
  • Exposure to occupational contaminants.
  • Active smoking within last 2 years.
  • Alcoholism.
  • Chronic systemic disease other than OSAS.
  • Treatment with vasoactive drugs or antioxidants
  • Respiratory infection or vaccination during the 6 weeks preceding the PSG1.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

Clamart, 92141, France

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveHypoxia

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pierre ESCOURROU, MD, PhD

    Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

    STUDY DIRECTOR

  • Gabriel ROISMAN, MD, PhD

    Assistance Publique - Hôpitaux de Paris, Hôpital Antoine Béclère

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 17, 2008

First Posted

March 31, 2008

Study Start

January 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

July 12, 2010

Record last verified: 2010-05

Locations

FR(1)