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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01042834
First received: January 5, 2010
Last updated: January 12, 2011
Last verified: January 2011
History of Changes
  Purpose

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


Condition Intervention
Healthy
 Other: Air pollution study on healthy volunteers.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Air Pollution on the Autonomic Nervous System Activity and the Presence of Sleep Apnea in Older Subjects: Longitudinal Multicentric Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • Frequency analysis of heart rate variability [ Time Frame: inclusion, 1 test night and 2 experimental nights ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analysis of sleep, diurnal somnolence, sleep latency and PRS impact on the life quality. [ Time Frame: 1 test night and 2 experimental nights ] [ Designated as safety issue: No ]
  • Hour index quantification of night respiratory events. [ Time Frame: 1 test night and 2 experimental nights ] [ Designated as safety issue: No ]
  • Hour index quantification of autonomic awakening during the sleep. [ Time Frame: 1 test night and 2 experimental nights ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: February 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: physiopathologic study

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.

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01042834

Locations
France
Hospices Civiles de Lyon
Lyon, France, 69000
CHU Saint-Etienne
Saint-Etienne, France, 42000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Investigators
Principal Investigator: Jean-Claude BARTHELEMY, MD-PhD CHU de Saint-Etienne
  More Information

No publications provided

Responsible Party: Clément CAILLAUX, Centre Hospitalier Universitaire de Saint-Etienne
ClinicalTrials.gov Identifier: NCT01042834     History of Changes
Other Study ID Numbers: 0508078, DGS 2006/0060
Study First Received: January 5, 2010
Last Updated: January 12, 2011
Health Authority: France: Direction Générale de la Santé
France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
air pollution
autonomic nervous system
sleep apnea
Heart rate variability
Healthy volunteers

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

ClinicalTrials.gov processed this record on May 23, 2013