HealthyPOLLAIRNCT01042834
Impact of Air Pollution on the Autonomic Nervous System Activity and the Presence of Sleep Apnea in Older Subjects
An observational study of Healthy, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial summary
Impact of air pollution on the autonomic nervous system activity and presence of sleep apnea in older subjects. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Air pollution study on healthy volunteers.
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2008to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The subjects will have to live in districts where important atmospheric pollution is established
Who may be able to join
- reside in Lyon and Saint-Etienne cities
- security social affiliated or beneficiary
- information note signed
Who cannot join
- heart rate disorders
- pacemaker
- tabacco addiction or second-hand smoke
- morbid obesity (BMI > 30)
- insulin-dependent diabetes
- chronic disease on treatment
- antiarrythmic treatments
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hospices Civiles de Lyon
Lyon, 69000
CHU Saint-Etienne
Saint-Etienne, 42000
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Air pollution study on healthy volunteers.
- Keywords
- air pollution, autonomic nervous system, sleep apnea, Heart rate variability, Healthy volunteers
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air pollution study on healthy volunteers.Other
Also called physiopathologic study
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.
| Study group | Role | What they receive |
|---|---|---|
| Air pollution | The subjects will have to live in districts where important atmospheric pollution is established Receives: Other: Air pollution study on healthy volunteers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency analysis of heart rate variability
Measured: 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.
Measured: 1 test night and 2 experimental nights
Hour index quantification of night respiratory events.
Measured: 1 test night and 2 experimental nights
Hour index quantification of autonomic awakening during the sleep.
Measured: 1 test night and 2 experimental nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startFeb 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Investigators
- Jean-Claude BARTHELEMY, MD-PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042834
- Sponsor's protocol ID
- 0508078
- Other IDs
- DGS 2006/0060
- Acronym
- POLLAIR
- Status last verified
- Jan 2011
- First submitted
- 5 Jan 2010
- Last updated
- 13 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Air Pollution on the Autonomic Nervous System Activity and the Presence of Sleep Apnea in Older Subjects: Longitudinal Multicentric Study
- ClinicalTrials.gov ID
- NCT01042834
- Acronym / sponsor ID
- POLLAIR / 0508078
- Conditions
- Healthy
- Keywords
- air pollution, autonomic nervous system, sleep apnea, Heart rate variability, Healthy volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Feb 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 6 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Impact of air pollution on the autonomic nervous system activity and presence of sleep apnea in older subjects.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Air pollution | – | Other: Air pollution study on healthy volunteers.The subjects will have to live in districts where important atmospheric pollution is established |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects will have to live in districts where important atmospheric pollution is established
Key inclusion criteria (3 listed)
- reside in Lyon and Saint-Etienne cities
- security social affiliated or beneficiary
- information note signed
Key exclusion criteria (7 listed)
- heart rate disorders
- pacemaker
- tabacco addiction or second-hand smoke
- morbid obesity (BMI > 30)
- insulin-dependent diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air pollution study on healthy volunteers.Also: physiopathologic studyThe 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 | Air pollution |
Primary outcome
Frequency analysis of heart rate variability
Time frame: inclusion, 1 test night and 2 experimental nights
3 secondary outcomes
Analysis of sleep, diurnal somnolence, sleep latency and PRS impact on the life quality.
Time frame: 1 test night and 2 experimental nights
Hour index quantification of night respiratory events.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Claude BARTHELEMY, MD-PhD principal investigator
CHU de Saint-Etienne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency analysis of heart rate variability (time frame: inclusion, 1 test night and 2 experimental nights). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2011.