Beneficial Health Effects of Living in Filtered Air Clinical Trial
— ELIFAOfficial 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.
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.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | December 2017 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 65 Years and older |
| Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Rusthuis Honighsdries | Scherpenheuvel | Limburg |
| Lead Sponsor | Collaborator |
|---|---|
| Hasselt University |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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, Kicinski 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 | No |
| Primary | 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. | The cardiovascular outcome is performed weekly during the 6 week period, changes from baseline measurement are studied | No |
| Primary | 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. | The cardiovascular outcome is performed weekly during the 6 week period, changes from baseline measurement are studied | No |
| Primary | 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. | The cardiovascular outcome is performed weekly during the 6 week period, changes from baseline measurement are studied | No |
| Primary | 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. | The cardiovascular outcome is performed weekly during the 6 week period, changes from baseline measurement are studied | No |
| Secondary | 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. | Weekly during the 6 week period, changes from baseline measurement are studied | No |
| Secondary | 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. | Weekly during the 6 week period, changes from baseline measurement are studied | No |
| Secondary | 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. | Weekly during the 6 week period, changes from baseline measurement are studied | No |