Cardiovascular Consequences of Intermittent Hypoxia in Healthy Subjects
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|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
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||Phase|
|Sleep Apnea Syndrome||Other: Chronic Intermittent Hypoxia||Not Applicable|
|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|
|Actual Primary Completion Date :||July 2007|
|Estimated Study Completion Date :||October 2008|
- 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.
- Blood Pressure [ Time Frame: Two Weeks ]
- 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 ]
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
|Pulmonary Function and sleep Lab, CHU Grenoble|
|Grenoble, France, 38 000|
|Principal Investigator:||Renaud Tamisier, MD, PhD||University Hospital, Grenoble|