NCT01042834

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2008

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

February 1, 2008

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

January 13, 2011

Status Verified

January 1, 2011

Enrollment Period

2.4 years

First QC Date

January 5, 2010

Last Update Submit

January 12, 2011

Conditions

Healthy

Keywords

air pollutionautonomic nervous systemsleep apneaHeart rate variabilityHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Frequency analysis of heart rate variability

    inclusion, 1 test night and 2 experimental nights

Secondary Outcomes (3)

  • Analysis of sleep, diurnal somnolence, sleep latency and PRS impact on the life quality.

    1 test night and 2 experimental nights

  • Hour index quantification of night respiratory events.

    1 test night and 2 experimental nights

  • Hour index quantification of autonomic awakening during the sleep.

    1 test night and 2 experimental nights

Study Arms (1)

Air pollution

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

Other: Air pollution study on healthy volunteers.

Interventions

Air pollution study on healthy volunteers.OTHER

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.

Also known as: physiopathologic study
Air pollution

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospices Civiles de Lyon

Lyon, 69000, France

Location

CHU Saint-Etienne

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Jean-Claude BARTHELEMY, MD-PhD

    CHU de Saint-Etienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 5, 2010

First Posted

January 6, 2010

Study Start

February 1, 2008

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

January 13, 2011

Record last verified: 2011-01

Locations

FR(2)