Air Pollution Reduction in the Elderly and Cardiovascular and Cognitive Outcomes
NCT02411240, Not applicable, Unknown, Hasselt University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Air Pollution Reduction in the Elderly and Cardiovascular and Cognitive Outcomes | ClinicalTrials.gov |
| NCT number | NCT02411240 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 60 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Hasselt University | ClinicalTrials.gov |
| Conditions | Beneficial Health Effects of Living in Filtered Air | ClinicalTrials.gov |
| Interventions | Air filtering | ClinicalTrials.gov |
| First posted | 2015-04-08 | ClinicalTrials.gov |
| Last updated | 2015-04-08 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Cognitive endpoints as assessed by the Neurobehavioral Evaluation System (NES-3) | 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. | ClinicalTrials.gov |
| Primary | Cardiovascular endpoint: Microvasculature | 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. | ClinicalTrials.gov |
| Primary | Cardiovascular endpoint: Macro vasculature (carotid intima media thickness) | 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. | ClinicalTrials.gov |
| Primary | Cardiovascular endpoint: Heart rate variability (24h) | 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. | ClinicalTrials.gov |
| Primary | Cardiovascular endpoint: Blood pressure | 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. | ClinicalTrials.gov |
| Secondary | Underlying mechanisms at the molecular level: Transcriptomics and Epigenetics | 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. | ClinicalTrials.gov |
| Secondary | Underlying mechanisms at the molecular level: Markers of inflammation, and oxidative stress and haematological markers | 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. | ClinicalTrials.gov |
| Secondary | Underlying mechanisms at the molecular level: Mitochondrial DNA damage | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)