Impact of Air Pollution on the Autonomic Nervous System Activity and the Presence of Sleep Apnea in Older Subjects (POLLAIR)

January 12, 2011 updated by: Centre Hospitalier Universitaire de Saint Etienne

Impact of Air Pollution on the Autonomic Nervous System Activity and the Presence of Sleep Apnea in Older Subjects: Longitudinal Multicentric Study

Impact of air pollution on the autonomic nervous system activity and presence of sleep apnea in older subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The relation between the air pollution and morbidity, cardiovascular mortality was increasing interest. Analyses show an increase of respiratory difficulty, but also cardiac deaths in the daytime when the atmospheric pollution was increased. It was demonstrated that health effects of ambient air pollution in subjects presenting cardiac or lung difficulty were important. Mechanisms show a possible relation to autonomic nervous system (ANS) deactivation and mortality. Particularly, the ageing and ANS reach would be more predictive of cardiovascular events. Thus, we suggest estimating in 60 healthy volunteers from 60 to 80 years old, the impact of the air pollution on the autonomic nervous system activity and sleep apnea consequences.

Study Type

Observational

Enrollment (Actual)

60

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
      • Lyon, France, 69000
        • Hospices Civiles de Lyon
      • Saint-Etienne, France, 42000
        • CHU Saint-Etienne

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

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The subjects will have to live in districts where important atmospheric pollution is established

Description

Inclusion Criteria:

  • reside in Lyon and Saint-Etienne cities
  • security social affiliated or beneficiary
  • information note signed

Exclusion Criteria:

  • heart rate disorders
  • pacemaker
  • tabacco addiction or second-hand smoke
  • morbid obesity (BMI > 30)
  • insulin-dependent diabetes
  • chronic disease on treatment
  • antiarrythmic treatments

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Air pollution
The subjects will have to live in districts where important atmospheric pollution is established
Other: Air pollution study on healthy volunteers.

The subjects are examined three times:

  • First the volunteers get used to equipments.
  • Second and third the volunteers sleep in a pollution or purified air.
Other Names:
  • physiopathologic study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency analysis of heart rate variability
Time Frame: inclusion, 1 test night and 2 experimental nights
inclusion, 1 test night and 2 experimental nights

Secondary Outcome Measures

Outcome Measure
Time Frame
Analysis of sleep, diurnal somnolence, sleep latency and PRS impact on the life quality.
Time Frame: 1 test night and 2 experimental nights
1 test night and 2 experimental nights
Hour index quantification of night respiratory events.
Time Frame: 1 test night and 2 experimental nights
1 test night and 2 experimental nights
Hour index quantification of autonomic awakening during the sleep.
Time Frame: 1 test night and 2 experimental nights
1 test night and 2 experimental nights

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Jean-Claude BARTHELEMY, MD-PhD, CHU de Saint-Etienne

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

February 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

January 5, 2010

First Submitted That Met QC Criteria

January 5, 2010

First Posted (Estimate)

January 6, 2010

Study Record Updates

Last Update Posted (Estimate)

January 13, 2011

Last Update Submitted That Met QC Criteria

January 12, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0508078
  • DGS 2006/0060 (Other Identifier: AFSSAPS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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