Back to resultsCardiovascular Consequences of Intermittent Hypoxia in Healthy Subjects
Primary Purpose
Sleep Apnea Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Chronic Intermittent Hypoxia
Sponsored by
About this trial
This is an interventional basic science trial for Sleep Apnea Syndrome focused on measuring Blood pressure, Hypertension, sympathetic control, chemosensitivity, baroreflex
Eligibility Criteria
Inclusion Criteria:
- Healthy subjects
Exclusion Criteria:
- Any history or significant medical condition
Sites / Locations
- Pulmonary Function and sleep Lab, CHU Grenoble
Outcomes
Primary Outcome Measures
Blood Pressure
Secondary Outcome Measures
Neuronal and humoral sympathetic control and vascular resistance.
Sleep quality
The ventilation under exposure and the long terms effect on ventilation control of CIH (central and peripheral chemoreflex)
Full Information
NCT ID
NCT00746928
First Posted
September 1, 2008
Last Updated
September 3, 2008
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT00746928
Brief Title
Cardiovascular Consequences of Intermittent Hypoxia in Healthy Subjects
Official Title
Cardiovascular Consequences of Intermittent Hypoxia in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
October 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndrome
Keywords
Blood pressure, Hypertension, sympathetic control, chemosensitivity, baroreflex
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Chronic Intermittent Hypoxia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood Pressure
Time Frame
Two Weeks
Secondary Outcome Measure Information:
Title
Neuronal and humoral sympathetic control and vascular resistance.
Time Frame
Two weeks
Title
Sleep quality
Time Frame
Two Weeks
Title
The ventilation under exposure and the long terms effect on ventilation control of CIH (central and peripheral chemoreflex)
Time Frame
two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy subjects
Exclusion Criteria:
Any history or significant medical condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renaud Tamisier, MD, PhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pulmonary Function and sleep Lab, CHU Grenoble
City
Grenoble
ZIP/Postal Code
38 000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Cardiovascular Consequences of Intermittent Hypoxia in Healthy Subjects
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