Cardiovascular Consequences of Intermittent Hypoxia in Healthy Subjects

September 3, 2008 updated by: University Hospital, Grenoble

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.

Study Overview

Status

Unknown

Conditions

Sleep Apnea Syndrome

Intervention / Treatment

Other: Chronic Intermittent Hypoxia

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Grenoble, France, 38 000
    - Pulmonary Function and sleep Lab, CHU Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Healthy subjects

Exclusion Criteria:

Any history or significant medical condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: BASIC_SCIENCE
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood Pressure Time Frame: Two Weeks	Two Weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (ACTUAL)

July 1, 2007

Study Completion (ANTICIPATED)

October 1, 2008

Study Registration Dates

First Submitted

September 1, 2008

First Submitted That Met QC Criteria

September 3, 2008

First Posted (ESTIMATE)

September 4, 2008

Study Record Updates

Last Update Posted (ESTIMATE)