We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cardiovascular Consequences of Intermittent Hypoxia in Healthy Subjects

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.
ClinicalTrials.gov Identifier: NCT00746928
Recruitment Status : Unknown
Verified September 2008 by University Hospital, Grenoble.
Recruitment status was:  Active, not recruiting
First Posted : September 4, 2008
Last Update Posted : September 4, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment
Sleep Apnea Syndrome Other: Chronic Intermittent Hypoxia

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Cardiovascular Consequences of Intermittent Hypoxia in Healthy Subjects
Study Start Date : September 2005
Primary Completion Date : July 2007
Estimated Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Posted: September 4, 2008    Key Record Dates
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