Cardiovascular Consequences of Intermittent Hypoxia in Healthy Subjects

Sleep Apnea Syndrome Clinical Trial

Official title:

Cardiovascular Consequences of Intermittent Hypoxia in Healthy Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00746928
• Other study ID #: 05-CHUG-23
• Status: Active, not recruiting
• Phase: N/A
• First received: September 1, 2008
• Last updated: September 3, 2008
• Start date: September 2005
• Est. completion date: October 2008

Study information

• Verified date: September 2008
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical CommitteeFrance: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: October 2008
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy subjects

Exclusion Criteria:

• Any history or significant medical condition

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Sleep Apnea Syndrome
• Sleep Apnea Syndromes

Intervention

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.

Locations

Country	Name	City	State
France	Pulmonary Function and sleep Lab, CHU Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure		Two Weeks	No
Secondary	Neuronal and humoral sympathetic control and vascular resistance.		Two weeks	No
Secondary	Sleep quality		Two Weeks	No
Secondary	The ventilation under exposure and the long terms effect on ventilation control of CIH (central and peripheral chemoreflex)		two weeks	No