Vehicular EnvironmentNCT02381626
DRIIVE (Data and Research on Interventions to Improve the Vehicular Environment)
A study testing HEPA air purifier, questionnaires and Log-book in people with Vehicular Environment, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to look at air quality in cabs and see if the air quality inside taxi cabs is connected to increased risks for lung and heart health problems. Another purpose of the study is to see if putting an air filter inside the car may help improve the air quality and lower health risks. Read more about this study
- Who is it for?
- Ages 21 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vehicular Environment
- What is being tested?
- HEPA air purifier, questionnaires and Log-book
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 18 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Drivers:
- Full-time New York City cab drivers;
- Non Smokers (assessed by modified BRFSS smoking question within screening tool) ;
- Male;
- Between the ages of 21 and 90;
- No immediate plans (within the next 3 months) to leave the City for vacation or for trips back to their home country
Show all 11Show fewer
- Driver for at least 3 years*;
- Driving schedule does not include overnight shifts, nor does driver have an additional job overnight;
- Own a smart phone (in order to collect heart rate variability data)
- Should self-report at least "Very well" level of English fluency (according to the standard US census question)
- Have working cigarette lighter receptacle/socket inside taxi cab *The requirement to have worked at least 3 years in the U.S. should minimize any acute health effects/disease due to high levels of contaminants associated with country of origin
Who cannot join
- Drivers:
- Smoker or uses smokeless tobacco products;
- Resides in a smoking household (where 1 or more household members smoke);
- Has a sleep disorder (including insomnia, delayed sleep phase syndrome (DSPS), narcolepsy, night terror, sleep apnea, sleep walking);
- Has a current or previous diagnosis of any type of cancer;
- Has a diagnosis of an inflammatory, autoimmune, or chronic infectious disease (including rheumatoid arthritis, lupus, chronic liver disease, multiple sclerosis, fibromyalgia, inflammatory bowel disease, psoriasis, HIV);
- Has a serious cardiopulmonary medical condition (including cardiovascular disease, congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), restrictive lung disease, interstitial lung disease, asthma, acute or chronic bronchitis, cystic fibrosis, pneumonia, tuberculosis, pneumoconiosis, pulmonary hypertension, pulmonary embolism, pleural effusion, pneumothorax, obesity hypoventilation syndrome, neuromuscular lung disease).
- Self reports -well‖ level of English fluency and indicates a preference for an interpreter.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to look at air quality in cabs and see if the air quality inside taxi cabs is connected to increased risks for lung and heart health problems. Another purpose of the study is to see if putting an air filter inside the car may help improve the air quality and lower health risks.
This is important because air pollution can be harmful to health. Air pollution is made up of very tiny particles (things) floating in the air around us, called particulate matter. Particulate matter is made up of dust, smoke, dirt, and gas fumes and can get into our bodies as we breathe. It has been linked to risk for lung cancer and heart disease. It is important because taxi drivers spend many hours of their day inside their cars.
The investigators hope that this study will help them find out if using air filters inside cabs will help lower the levels of pollution in cabs and reduce its effects on the health of taxi drivers. They will use these results to educate the taxi driver community.
Read the detailed description
DRIIVE (Data and Research on Interventions to Improve the Vehicular Environment) is a community-engaged translational pilot project that will utilize a three parallel arm design to obtain preliminary data on associations between Particulate Matter (PM)/air pollution and physiologic measurements and biomarkers in taxi drivers, and to determine the impact of a HEPA filter (to remove PM and volatile organic compounds) intervention on such physiologic measurements and biomarkers. DRIIVE is funded by the New York State Department of Health Empire Clinical Research Investigator Program (ECRIP), which trains physicians in clinical research in New York. Drivers will be randomized to one of two groups: Intervention or Wait-list Control. In total, two groups of 14 participants in each group will be recruited: 1) Wait List Control group, who will receive a HEPA filter at the end of the 1 month participation period, and 2) Intervention group, who will receive a HEPA filter two weeks into their participation period. The project will be completed within a 2 year timeframe.
- Conditions
- Vehicular Environment
- Being tested
- HEPA air purifier, questionnaires, Log-book, Urine sample
- Keywords
- HEPA filter, 14-247
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEPA air purifierDevice
air purifiers to remove PM and volatile organic compounds will be placed in drivers cars
questionnairesBehavioural
Log-bookOther
PM and biological measurements
Urine sampleOther
PAH (Polycyclic Aromatic Hydrocarbon) will be assessed via urine sample collection of Urinary 1 hydroxy pyrene and particulate matter collected via Polyurethane Foam Filter (PUF) sampler
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | During the first 2 weeks, measurements (e.g. biological markers and air monitoring) will be taken under usual conditions. At the end of the initial two weeks, portable HEPA air purifiers (136) will be placed in the Intervention Group drivers' cars and the air monitoring and biological parameters will be repeated for another 2-week period, to determine changes in PM levels and physiological measurements as a result of this targeted intervention. Receives: Device: HEPA air purifier; Behavioral: questionnaires; Other: Log-book; Other: Urine sample |
| Wait-list Control Group | Experimental | During the first 2 weeks, measurements (e.g. biological markers and air monitoring) will be taken under usual conditions. The Wait-list Control Group drivers will not receive a HEPA air purifier at this time, but will also have the air monitoring and biological parameters repeated for another 2 weeks. At the end of the 1 month period of measurements for both groups of drivers, the Wait-list drivers will then receive a HEPA air purifier, so that they may also potentially benefit from the intervention being tested in this study, but no further measurements will be taken. Receives: Device: HEPA air purifier; Behavioral: questionnaires; Other: Log-book; Other: Urine sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect Preliminary Data on In-vehicle Excess Particulate Matter (PM) Exposure
monitor/report the PM levels as time-averaged sample (hourly averages) that will be monitored at work site and at homes across all groups
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startDec 2014
- Primary completion18 Oct 2020
- Study completion18 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vehicular EnvironmentStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- New York University, New York State Department of Health, The City College of New York
- Responsible party
- Sponsor
- Investigators
- Jennifer Leng, MD, MPH, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381626
- Sponsor's protocol ID
- 14-247
- Status last verified
- Feb 2021
- First submitted
- 24 Feb 2015
- Last updated
- 5 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DRIIVE (Data and Research on Interventions to Improve the Vehicular Environment)
- ClinicalTrials.gov ID
- NCT02381626
- Acronym / sponsor ID
- 14-247
- Conditions
- Vehicular Environment
- Keywords
- HEPA filter, 14-247
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- New York University, New York State Department of Health, The City College of New York
- Study start
- Dec 2014
- Primary completion
- 18 Oct 2020 (actual)
- Study completion
- 18 Oct 2020 (actual)
- First posted
- 6 Mar 2015 (estimated)
- Results
- Posted 5 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to look at air quality in cabs and see if the air quality inside taxi cabs is connected to increased risks for lung and heart health problems. Another purpose of the study is to see if putting an air filter inside the car may help improve the air quality and lower health risks.
This is important because air pollution can be harmful to health. Air pollution is made up of very tiny particles (things) floating in the air around us, called particulate matter. Particulate matter is made up of dust, smoke, dirt, and gas fumes and can get into our bodies as we breathe. It has been linked to risk for lung cancer and heart disease. It is important because taxi drivers spend many hours of their day inside their cars.
The investigators hope that this study will help them find out if using air filters inside cabs will help lower the levels of pollution in cabs and reduce its effects on the health of taxi drivers. They will use these results to educate the taxi driver community.
Detailed description
DRIIVE (Data and Research on Interventions to Improve the Vehicular Environment) is a community-engaged translational pilot project that will utilize a three parallel arm design to obtain preliminary data on associations between Particulate Matter (PM)/air pollution and physiologic measurements and biomarkers in taxi drivers, and to determine the impact of a HEPA filter (to remove PM and volatile organic compounds) intervention on such physiologic measurements and biomarkers. DRIIVE is funded by the New York State Department of Health Empire Clinical Research Investigator Program (ECRIP), which trains physicians in clinical research in New York. Drivers will be randomized to one of two groups: Intervention or Wait-list Control. In total, two groups of 14 participants in each group will be recruited: 1) Wait List Control group, who will receive a HEPA filter at the end of the 1 month participation period, and 2) Intervention group, who will receive a HEPA filter two weeks into their participation period. The project will be completed within a 2 year timeframe.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: HEPA air purifier, Behavioral: questionnaires, Other: Log-book, Other: Urine sampleDuring the first 2 weeks, measurements (e.g. biological markers and air monitoring) will be taken under usual conditions. At the end of the initial two weeks, portable HEPA air purifiers (136) will be placed in the Intervention Group drivers' cars and the air monitoring and biological parameters will be repeated for another 2-week period, to determine changes in PM levels and physiological measurements as a result of this targeted intervention. |
| Wait-list Control Group | Experimental | Device: HEPA air purifier, Behavioral: questionnaires, Other: Log-book, Other: Urine sampleDuring the first 2 weeks, measurements (e.g. biological markers and air monitoring) will be taken under usual conditions. The Wait-list Control Group drivers will not receive a HEPA air purifier at this time, but will also have the air monitoring and biological parameters repeated for another 2 weeks. At the end of the 1 month period of measurements for both groups of drivers, the Wait-list drivers will then receive a HEPA air purifier, so that they may also potentially benefit from the intervention being tested in this study, but no further measurements will be taken. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Full-time New York City cab drivers;
- Non Smokers (assessed by modified BRFSS smoking question within screening tool) ;
- Male;
- Between the ages of 21 and 90;
- No immediate plans (within the next 3 months) to leave the City for vacation or for trips back to their home country
Key exclusion criteria (8 listed)
- Smoker or uses smokeless tobacco products;
- Resides in a smoking household (where 1 or more household members smoke);
- Has a sleep disorder (including insomnia, delayed sleep phase syndrome (DSPS), narcolepsy, night terror, sleep apnea, sleep walking);
- Has a current or previous diagnosis of any type of cancer;
- Has a diagnosis of an inflammatory, autoimmune, or chronic infectious disease (including rheumatoid arthritis, lupus, chronic liver disease, multiple sclerosis, fibromyalgia, inflammatory bowel disease, psoriasis, HIV);
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 |
|---|---|---|
| HEPA air purifierair purifiers to remove PM and volatile organic compounds will be placed in drivers cars | Device | Intervention Group, Wait-list Control Group |
| questionnaires | Behavioural | Intervention Group, Wait-list Control Group |
| Log-bookPM and biological measurements | Other | Intervention Group, Wait-list Control Group |
| Urine samplePAH (Polycyclic Aromatic Hydrocarbon) will be assessed via urine sample collection of Urinary 1 hydroxy pyrene and particulate matter collected via Polyurethane Foam Filter (PUF) sampler | Other | Intervention Group, Wait-list Control Group |
Primary outcome
Collect Preliminary Data on In-vehicle Excess Particulate Matter (PM) Exposure
Time frame: 2 years
monitor/report the PM levels as time-averaged sample (hourly averages) that will be monitored at work site and at homes across all groups
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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.
Jennifer Leng, MD, MPH principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEPA air purifier, questionnaires and Log-book in people with Vehicular Environment, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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 11 inclusion and 8 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 5 Oct 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 5 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Collect Preliminary Data on In-vehicle Excess Particulate Matter (PM) Exposure (time frame: 2 years). 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 5 Oct 2021.