Air Pollution Reduction in the Elderly and Cardiovascular and Cognitive Outcomes (ELIFA)

April 2, 2015 updated by: Tim Nawrot, Hasselt University

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. 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.

  2. 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.

  3. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 65 years or older
  • Non- smoker
  • Not bed-ridden
  • Able to give informed consent.

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

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Air filtering in the living room
GENANO tubes, GENANO Benelux; Heusen-Zolder, Belgium
Device: Air filtering
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.
Other Names:
  • GENANO tubes, GENANO Benelux; Heusen-Zolder, Belgium

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
The cognitive outcome is performed weekly during the 6 week period, changes from baseline measurement are studied
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.
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)
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.
The cardiovascular outcome is performed weekly during the 6 week period, changes from baseline measurement are studied
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.
The cardiovascular outcome is performed weekly during the 6 week period, changes from baseline measurement are studied
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.
The cardiovascular outcome is performed weekly during the 6 week period, changes from baseline measurement are studied

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 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.
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
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.
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
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.
Weekly during the 6 week period, changes from baseline measurement are studied

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hasselt University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tim S Nawrot, PhD, Hasselt University

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ELIFA_TN

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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