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Cardiovascular Consequences of Intermittent Hypoxia in Healthy Subjects

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by University Hospital, Grenoble.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00746928
First received: September 1, 2008
Last updated: September 3, 2008
Last verified: September 2008
History of Changes
  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: Open Label
Primary Purpose: Basic Science
Official Title: Cardiovascular Consequences of Intermittent Hypoxia in Healthy Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Blood Pressure [ Time Frame: Two Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neuronal and humoral sympathetic control and vascular resistance. [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
  • Sleep quality [ Time Frame: Two Weeks ] [ Designated as safety issue: No ]
  • The ventilation under exposure and the long terms effect on ventilation control of CIH (central and peripheral chemoreflex) [ Time Frame: two weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects

Exclusion Criteria:

  • Any history or significant medical condition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: TAMISIER Renaud, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00746928     History of Changes
Other Study ID Numbers: 05-CHUG-23
Study First Received: September 1, 2008
Last Updated: September 3, 2008
Health Authority: France: Institutional Ethical Committee
France: Direction Générale de la Santé

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

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

ClinicalTrials.gov processed this record on May 21, 2013