Beneficial Health Effects of Living in Filtered AirELIFANCT02411240
Air Pollution Reduction in the Elderly and Cardiovascular and Cognitive Outcomes
A study testing Air filtering in people with Beneficial Health Effects of Living in Filtered Air, run by Hasselt University at 1 site in Belgium.
Trial summary
Short-term and chronic exposure to ambient levels of particulate matter (PM) is associated with increased morbidity and mortality related to respiratory and cardiovascular disease. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Beneficial Health Effects of Living in Filtered Air
- What is being tested?
- Air filtering
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2014to Dec 2017
- Phase
- Interventional
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- The selection is made on the basis of the mental state of candidate participants, this primary selection is based on the advice of the directors or head nurses of the elderly homes, as in the investigators' previous studies (Jacobs et al., 2012).
- A documented minimental state examination (MMSE) will be performed and the participation of the candidates will depend on a priori determined criteria (score of 23) and the ability of the possible participant to perform the NES tests (cognitive test), done a priori of enrolment.
Who cannot join
- 65 years or older
- Non- smoker
- Not bed-ridden
- Able to give informed consent.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Rusthuis Honighsdries
Scherpenheuvel, Limburg, 3271
Harry Roels, PhD, harry.roels@uhasselt.be
About this study
Official title: Air Pollution Reduction in the Elderly and Cardiovascular and Cognitive Outcomes, an Intervention Study
Short-term and chronic exposure to ambient levels of particulate matter (PM) is associated with increased morbidity and mortality related to respiratory and cardiovascular disease. Proposed biological pathways imply that particle-induced inflammation plays a role in activating the vascular endothelium and altering vascular function. Accumulating evidence suggests that outdoor air pollution has a significant impact on central nervous system health and disease and living in conditions with elevated air pollution has been linked to decreased cognitive function.
Only recently was shown that reductions in ambient levels of PM2.5 were associated with improvements in life expectancy. However, studies of the beneficial effects of improved indoor air quality on healthy humans are lacking.
Read more
With this project the investigators intend to study the effects of rooms with clean air in the elderly with the emphasis on cardiovascular and cognitive function. The investigators hypothesise that by means of air cleaning, controlled and reduced exposure has a positive effect on cardiovascular parameters such as blood pressure, heart rate variability, macro- and microcirculation and on neurobehavioral function. The investigators substantiate these outcomes with potential mechanisms of action at the transcript and epigenetic level as with hematological parameters, markers of inflammation, lipid and protein oxidation products and mitochondrial DNA damage. To achieve these goals there is a specific need to study the elderly, as they appear to have elevated susceptibility and have the largest attributable risk related to indoor PM, as they spend more time indoors. Suited concepts for study location are elderly homes ("service flats") and retirement homes.
The "ELiFA"-cohort stands for Elderly Living in Filtered Air consisting of an intervention study during 2-week periods of a pre-purification (baseline), active purification and a post purification period.
Read the detailed description
- Study Population and Design Persons living in ''service flats'' or retirement homes are healthy elderly who respectively live semi-independently or dependently. The elderly homes will be located in Flanders, Belgium. Persons are included if they are 65 years or older, not bedridden, non- smoker and able to give informed consent. This selection is made on the basis of the mental state of candidate participants, this primary selection is based on the advice of the directors or head nurses of the elderly homes. A documented minimental state examination (MMSE) will be performed and the participation of the candidates will depend on a priori determined criteria (score 23) and the ability of the possible participant to perform the NES tests (cognitive test), done a priori of enrolment. The project design is an intervention study of in total 6 weeks, starting with a baseline pre-purification period, a 2-week active purification period and a 2-week post purification period. Each participant is his/her own control, excluding confounding by factors that are stable within an individual over time but vary between participants. The device (GENANO tubes, GENANO Benelux; Heusen-Zolder, België) is placed in the living room of each apartment during the study period. These kinds of air purification devices are used in medical settings (cleanrooms, medical practice) and give us the opportunity to create a well-controlled experimental real life setting. Ultra fine particle (UFP) (Aerasense, Philips), PM10-2.5 and total suspended particulates (TSP) (Aerocet, MetOne) are monitored. Blood and urine are sampled every week in the morning at the same hour per participant to avoid problems due to diurnal variation. The participants will be asked to fill in a questionnaire. For the duration of the study, the investigators ask the participants to keep their windows closed.
- Primary Endpoints The primary endpoints focus on changes in the cardiovascular en neurobiological function. 2.1 Cardiovascular function. The cardiovascular measurements are conducted non-invasively and are wide ranging in order to comprehensively study these effects. 2.1.1. Microvasculature: After pupillary dilation, digital images of both the retinas are obtained using a digital retinal camera (Canon CR-2 Digital Retinal Camera). 2.1.2. Macro vasculature: The distensibility and intermedia thickness of the carotid artery are measured by echo-graphical imaging with the esaote MY LAB ™ ONE mobil device. 2.1.3.Heart rate variability: With a mobile ECG sensor (Biopatch, Zephyr) the heart rate variability (HRV) is continuously monitored for several 24h periods during the 3 phases of the study. 2.1.4. Blood pressure: Using Stabil-O-Graph devices the blood pressure is determined 5 consecutive times for every time point. 2.2 Cognitive function The investigators assess the neurobehavioral function with the Neurobehavioral Evaluation System (NES-3). Neurobehavioral Evaluation System (NES) is a computerised battery of tests developed to study the neurological effects of an exposure to environmental agents. The investigators use the digit span test, the continuous performance and the Stroop test.
- Secondary Endpoints The investigators delineate these outcomes with secondary endpoints to find potential mechanisms of action at the transcript and epigenetic level as with on haematological parameters, markers of inflammation and lipid and protein oxidation products and mitochondrial DNA damage.
3.1. Transcriptomics and Epigenetics The investigators study underlying mechanisms either by full transcriptome analysis and gene specific transcription patterns as well as by specific hypothesis driven microRNA studies. Epigenetic profiles are studied by gene specific methylation sequencing.
3.2. Haematological measurements, markers of inflammation, and oxidative stress.
The investigators measure hemoglobin, red blood cells, fibrinogen, platelets, coagulation factors (II + VII + X), IL-6 and urinary 8-oxo-7,8-dihydro-2'-deoxyguanosine (8-oxo-dG).
3.3. Mitochondrial DNA damage The investigators measure the mitochondrial DNA content relative to nuclear DNA by means of qPCR, which is a measure of DNA damage and can give an indication of the need to repair mitochondrial DNA damage. As this parameter is an early sensor of DNA-damage these samples will be collected from the whole blood tubes.
- Being tested
- Air filtering
- Keywords
- Air filtration, cardiovascular health, cognition, particulate matter, mitochondrial DNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air filteringDevice
Also called GENANO tubes, GENANO Benelux; Heusen-Zolder, Belgium
The air filter will be placed in the living room of the elderly people. The efficiency of this device has been tested and a drop of ultrafine particles of more then 70 % is achieved.
| Study group | Role | What they receive |
|---|---|---|
| Air filtering in the living room | Other | GENANO tubes, GENANO Benelux; Heusen-Zolder, Belgium Receives: Device: Air filtering |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive endpoints as assessed by the Neurobehavioral Evaluation System (NES-3)
The investigators assess the neurobehavioral function with the Neurobehavioral Evaluation System (NES-3) (Baker et al., 1985, Kiciński et al., 2012). Neurobehavioral Evaluation System (NES) is a computerized battery of tests developed to study the neurological effects of an exposure to environmental agents. They use the digit span test, the continuous performance and the Stroop test.
Measured: The cognitive outcome is performed weekly during the 6 week period, changes from baseline measurement are studied
Cardiovascular endpoint: Microvasculature
Microvasculature imaging is performed to establish changes in cardiovascular status due to living in filtered air. Microvasculature is measured by taking a digital picture of the retina vasculature using a digital retinal camera (Canon CR-2 Digital Retinal Camera), the diameter of the retinal vasculature is determined.
Measured: The cardiovascular outcome is performed weekly during the 6 week period, changes from baseline measurement are studied
Cardiovascular endpoint: Macro vasculature (carotid intima media thickness)
Macro vasculature is determined to establish changes in cardiovascular status due to living in filtered air. Macro vasculature is determined by measuring the carotid intima media thickness using the esaote MY LAB ™ ONE mobil device.
Measured: The cardiovascular outcome is performed weekly during the 6 week period, changes from baseline measurement are studied
Cardiovascular endpoint: Heart rate variability (24h)
Heart rate variability (hrv) measurements are performed to establish changes in cardiovascular status due to living in filtered air. Hrv (24h) is measured using a Zephyr biopatch attached to the chest.
Measured: The cardiovascular outcome is performed weekly during the 6 week period, changes from baseline measurement are studied
Cardiovascular endpoint: Blood pressure
Blood pressure is measured to establish changes in cardiovascular status due to living in filtered air. Using Stabil-O-Graph devices the blood pressure is determined 5 consecutive times for every time point.
Measured: The cardiovascular outcome is performed weekly during the 6 week period, changes from baseline measurement are studied
Secondary outcomes (3)
Underlying mechanisms at the molecular level: Transcriptomics and Epigenetics
Underlying mechanisms are studied either by full transcriptome analysis and gene specific transcription patterns as well as by specific hypothesis driven microRNA studies. Epigenetic profiles are studied by gene specific methylation sequencing. This is a composite outcome studying the processes influencing gene-expression.
Measured: Weekly during the 6 week period, changes from baseline measurement are studied
Underlying mechanisms at the molecular level: Markers of inflammation, and oxidative stress and haematological markers
The investigators measure hemoglobin, red blood cells, fibrinogen, platelets, coagulation factors (II + VII + X), IL-6 and urinary 8-oxo-7,8-dihydro-2'-deoxyguanosine (8-oxo-dG). This is a composite outcome studying inflammation and oxidative stress, 2 processes possibly underlying the health effects of air pollutants.
Measured: Weekly during the 6 week period, changes from baseline measurement are studied
Underlying mechanisms at the molecular level: Mitochondrial DNA damage
The mitochondrial DNA content relative to nuclear DNA is determined by qPCR , which is a measure of DNA damage and can give an indication of the need to repair mitochondrial DNA damage.
Measured: Weekly during the 6 week period, changes from baseline measurement are studied
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startJul 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Beneficial Health Effects of Living in Filtered AirStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Nawrot, Hasselt University
- Investigators
- Tim S Nawrot, PhD, Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411240
- Sponsor's protocol ID
- ELIFA_TN
- Acronym
- ELIFA
- Status last verified
- Apr 2015
- First submitted
- 21 Jul 2014
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Air Pollution Reduction in the Elderly and Cardiovascular and Cognitive Outcomes, an Intervention Study
- ClinicalTrials.gov ID
- NCT02411240
- Acronym / sponsor ID
- ELIFA / ELIFA_TN
- Keywords
- Air filtration, cardiovascular health, cognition, particulate matter, mitochondrial DNA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 8 Apr 2015 (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.
Short-term and chronic exposure to ambient levels of particulate matter (PM) is associated with increased morbidity and mortality related to respiratory and cardiovascular disease. Proposed biological pathways imply that particle-induced inflammation plays a role in activating the vascular endothelium and altering vascular function. Accumulating evidence suggests that outdoor air pollution has a significant impact on central nervous system health and disease and living in conditions with elevated air pollution has been linked to decreased cognitive function.
Only recently was shown that reductions in ambient levels of PM2.5 were associated with improvements in life expectancy. However, studies of the beneficial effects of improved indoor air quality on healthy humans are lacking.
With this project the investigators intend to study the effects of rooms with clean air in the elderly with the emphasis on cardiovascular and cognitive function. The investigators hypothesise that by means of air cleaning, controlled and reduced exposure has a positive effect on cardiovascular parameters such as blood pressure, heart rate variability, macro- and microcirculation and on neurobehavioral function. The investigators substantiate these outcomes with potential mechanisms of action at the transcript and epigenetic level as with hematological parameters, markers of inflammation, lipid and protein oxidation products and mitochondrial DNA damage. To achieve these goals there is a specific need to study the elderly, as they appear to have elevated susceptibility and have the largest attributable risk related to indoor PM, as they spend more time indoors. Suited concepts for study location are elderly homes ("service flats") and retirement homes.
The "ELiFA"-cohort stands for Elderly Living in Filtered Air consisting of an intervention study during 2-week periods of a pre-purification (baseline), active purification and a post purification period.
Detailed description
- Study Population and Design Persons living in ''service flats'' or retirement homes are healthy elderly who respectively live semi-independently or dependently. The elderly homes will be located in Flanders, Belgium. Persons are included if they are 65 years or older, not bedridden, non- smoker and able to give informed consent. This selection is made on the basis of the mental state of candidate participants, this primary selection is based on the advice of the directors or head nurses of the elderly homes. A documented minimental state examination (MMSE) will be performed and the participation of the candidates will depend on a priori determined criteria (score 23) and the ability of the possible participant to perform the NES tests (cognitive test), done a priori of enrolment. The project design is an intervention study of in total 6 weeks, starting with a baseline pre-purification period, a 2-week active purification period and a 2-week post purification period. Each participant is his/her own control, excluding confounding by factors that are stable within an individual over time but vary between participants. The device (GENANO tubes, GENANO Benelux; Heusen-Zolder, België) is placed in the living room of each apartment during the study period. These kinds of air purification devices are used in medical settings (cleanrooms, medical practice) and give us the opportunity to create a well-controlled experimental real life setting. Ultra fine particle (UFP) (Aerasense, Philips), PM10-2.5 and total suspended particulates (TSP) (Aerocet, MetOne) are monitored. Blood and urine are sampled every week in the morning at the same hour per participant to avoid problems due to diurnal variation. The participants will be asked to fill in a questionnaire. For the duration of the study, the investigators ask the participants to keep their windows closed.
- Primary Endpoints The primary endpoints focus on changes in the cardiovascular en neurobiological function. 2.1 Cardiovascular function. The cardiovascular measurements are conducted non-invasively and are wide ranging in order to comprehensively study these effects. 2.1.1. Microvasculature: After pupillary dilation, digital images of both the retinas are obtained using a digital retinal camera (Canon CR-2 Digital Retinal Camera). 2.1.2. Macro vasculature: The distensibility and intermedia thickness of the carotid artery are measured by echo-graphical imaging with the esaote MY LAB ™ ONE mobil device. 2.1.3.Heart rate variability: With a mobile ECG sensor (Biopatch, Zephyr) the heart rate variability (HRV) is continuously monitored for several 24h periods during the 3 phases of the study. 2.1.4. Blood pressure: Using Stabil-O-Graph devices the blood pressure is determined 5 consecutive times for every time point. 2.2 Cognitive function The investigators assess the neurobehavioral function with the Neurobehavioral Evaluation System (NES-3). Neurobehavioral Evaluation System (NES) is a computerised battery of tests developed to study the neurological effects of an exposure to environmental agents. The investigators use the digit span test, the continuous performance and the Stroop test.
- Secondary Endpoints The investigators delineate these outcomes with secondary endpoints to find potential mechanisms of action at the transcript and epigenetic level as with on haematological parameters, markers of inflammation and lipid and protein oxidation products and mitochondrial DNA damage.
3.1. Transcriptomics and Epigenetics The investigators study underlying mechanisms either by full transcriptome analysis and gene specific transcription patterns as well as by specific hypothesis driven microRNA studies. Epigenetic profiles are studied by gene specific methylation sequencing.
3.2. Haematological measurements, markers of inflammation, and oxidative stress.
The investigators measure hemoglobin, red blood cells, fibrinogen, platelets, coagulation factors (II + VII + X), IL-6 and urinary 8-oxo-7,8-dihydro-2'-deoxyguanosine (8-oxo-dG).
3.3. Mitochondrial DNA damage The investigators measure the mitochondrial DNA content relative to nuclear DNA by means of qPCR, which is a measure of DNA damage and can give an indication of the need to repair mitochondrial DNA damage. As this parameter is an early sensor of DNA-damage these samples will be collected from the whole blood tubes.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Air filtering in the living room | Other | Device: Air filteringGENANO tubes, GENANO Benelux; Heusen-Zolder, Belgium |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- The selection is made on the basis of the mental state of candidate participants, this primary selection is based on the advice of the directors or head nurses of the elderly homes, as in the investigators' previous studies (Jacobs et al., 2012).
- A documented minimental state examination (MMSE) will be performed and the participation of the candidates will depend on a priori determined criteria (score of 23) and the ability of the possible participant to perform the NES tests (cognitive test), done a priori of enrolment.
Key exclusion criteria (4 listed)
- 65 years or older
- Non- smoker
- Not bed-ridden
- Able to give informed consent.
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 filteringAlso: GENANO tubes, GENANO Benelux; Heusen-Zolder, BelgiumThe air filter will be placed in the living room of the elderly people. The efficiency of this device has been tested and a drop of ultrafine particles of more then 70 % is achieved. | Device | Air filtering in the living room |
Primary outcome
Cognitive endpoints as assessed by the Neurobehavioral Evaluation System (NES-3)
Time frame: The cognitive outcome is performed weekly during the 6 week period, changes from baseline measurement are studied
The investigators assess the neurobehavioral function with the Neurobehavioral Evaluation System (NES-3) (Baker et al., 1985, Kiciński et al., 2012). Neurobehavioral Evaluation System (NES) is a computerized battery of tests developed to study the neurological effects of an exposure to environmental agents. They use the digit span test, the continuous performance and the Stroop test.
Cardiovascular endpoint: Microvasculature
Time frame: The cardiovascular outcome is performed weekly during the 6 week period, changes from baseline measurement are studied
Microvasculature imaging is performed to establish changes in cardiovascular status due to living in filtered air. Microvasculature is measured by taking a digital picture of the retina vasculature using a digital retinal camera (Canon CR-2 Digital Retinal Camera), the diameter of the retinal vasculature is determined.
Cardiovascular endpoint: Macro vasculature (carotid intima media thickness)
Time frame: The cardiovascular outcome is performed weekly during the 6 week period, changes from baseline measurement are studied
Macro vasculature is determined to establish changes in cardiovascular status due to living in filtered air. Macro vasculature is determined by measuring the carotid intima media thickness using the esaote MY LAB ™ ONE mobil device.
Cardiovascular endpoint: Heart rate variability (24h)
Time frame: The cardiovascular outcome is performed weekly during the 6 week period, changes from baseline measurement are studied
Heart rate variability (hrv) measurements are performed to establish changes in cardiovascular status due to living in filtered air. Hrv (24h) is measured using a Zephyr biopatch attached to the chest.
Cardiovascular endpoint: Blood pressure
Time frame: The cardiovascular outcome is performed weekly during the 6 week period, changes from baseline measurement are studied
Blood pressure is measured to establish changes in cardiovascular status due to living in filtered air. Using Stabil-O-Graph devices the blood pressure is determined 5 consecutive times for every time point.
3 secondary outcomes
Underlying mechanisms at the molecular level: Transcriptomics and Epigenetics
Time frame: Weekly during the 6 week period, changes from baseline measurement are studied
Underlying mechanisms at the molecular level: Markers of inflammation, and oxidative stress and haematological markers
Time frame: Weekly during the 6 week period, changes from baseline measurement are studied
Underlying mechanisms at the molecular level: Mitochondrial DNA damage
Time frame: Weekly during the 6 week period, changes from baseline measurement are studied
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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.
Tim S Nawrot, PhD principal investigator
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air filtering in people with Beneficial Health Effects of Living in Filtered Air, run by Hasselt University at 1 site in Belgium.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tim S Nawrot, PhD (+3211268382, tim.nawrot@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive endpoints as assessed by the Neurobehavioral Evaluation System (NES-3) (time frame: The cognitive outcome is performed weekly during the 6 week period, changes from baseline measurement are studied). The study lists 5 primary outcomes in all. 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 8 Apr 2015.