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Cardiovascular Consequences of Intermittent Hypoxia in Healthy Subjects

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2008 by University Hospital, Grenoble.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00746928
First Posted: September 4, 2008
Last Update Posted: September 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Grenoble
  Purpose

The study is a prospective field evaluation to assess the effects of the chronic Intermittent Hypoxia exposure in 12 healthy humans.

Precisely, the study was designed to :

Set up a new model of Chronic Intermittent Hypoxia (CIH) applied to healthy human. This CIH is mimicking the CIH undergone by patients suffering from Sleep Apnea Syndrome.

Evaluate the cardiovascular effect of CIH. Neuronal and humoral sympathetic control, blood pressure control, vascular resistance.

Evaluate the Sleep quality, the ventilation under exposure and the long terms effect on ventilation control of CIH (central and peripheral chemoreflex).

Investigates the biological aspects of CIH exposure.


Condition Intervention
Sleep Apnea Syndrome Other: Chronic Intermittent Hypoxia

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Cardiovascular Consequences of Intermittent Hypoxia in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Blood Pressure [ Time Frame: Two Weeks ]

Secondary Outcome Measures:
  • Neuronal and humoral sympathetic control and vascular resistance. [ Time Frame: Two weeks ]
  • Sleep quality [ Time Frame: Two Weeks ]
  • The ventilation under exposure and the long terms effect on ventilation control of CIH (central and peripheral chemoreflex) [ Time Frame: two weeks ]

Enrollment: 12
Study Start Date: September 2005
Estimated Study Completion Date: October 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Chronic Intermittent Hypoxia
    Chronic Intermittent Hypoxia mimicking the CIH undergone by patients suffering from Sleep Apnea Syndrome, is applied to Healthy subject during 8 hours a day (nights) for a 14 days period. The cycle of intermittent Hypoxia is 30 drop in SaO2 per hours with a 10% decrease in SaO2.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects

Exclusion Criteria:

  • Any history or significant medical condition
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00746928


Locations
France
Pulmonary Function and sleep Lab, CHU Grenoble
Grenoble, France, 38 000
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Renaud Tamisier, MD, PhD University Hospital, Grenoble
  More Information

Responsible Party: TAMISIER Renaud, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00746928     History of Changes
Other Study ID Numbers: 05-CHUG-23
First Submitted: September 1, 2008
First Posted: September 4, 2008
Last Update Posted: September 4, 2008
Last Verified: September 2008

Keywords provided by University Hospital, Grenoble:
Blood pressure
Hypertension
sympathetic control
chemosensitivity
baroreflex

Additional relevant MeSH terms:
Hypoxia
Sleep Apnea Syndromes
Signs and Symptoms, Respiratory
Signs and Symptoms
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases