NCT00746928

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2008

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

September 4, 2008

Status Verified

September 1, 2008

Enrollment Period

1.8 years

First QC Date

September 1, 2008

Last Update Submit

September 3, 2008

Conditions

Sleep Apnea Syndrome

Keywords

Blood pressureHypertensionsympathetic controlchemosensitivitybaroreflex

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure

    Two Weeks

Secondary Outcomes (3)

  • Neuronal and humoral sympathetic control and vascular resistance.

    Two weeks

  • Sleep quality

    Two Weeks

  • The ventilation under exposure and the long terms effect on ventilation control of CIH (central and peripheral chemoreflex)

    two weeks

Interventions

Chronic Intermittent HypoxiaOTHER

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects

You may not qualify if:

  • Any history or significant medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pulmonary Function and sleep Lab, CHU Grenoble

Grenoble, 38 000, France

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesHypertension

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Renaud Tamisier, MD, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2008

First Posted

September 4, 2008

Study Start

September 1, 2005

Primary Completion

July 1, 2007

Study Completion

October 1, 2008

Last Updated

September 4, 2008

Record last verified: 2008-09

Locations

FR(1)