NCT02381626

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2020

Completed
12 months until next milestone

Results Posted

Study results publicly available

October 5, 2021

Completed
Last Updated

October 5, 2021

Status Verified

February 1, 2021

Enrollment Period

5.9 years

First QC Date

February 24, 2015

Results QC Date

September 8, 2021

Last Update Submit

September 8, 2021

Conditions

Vehicular Environment

Keywords

HEPA filter14-247

Outcome Measures

Primary Outcomes (1)

  • 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

    2 years

Study Arms (2)

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.

Device: HEPA air purifierBehavioral: questionnairesOther: Log-bookOther: 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.

Device: HEPA air purifierBehavioral: questionnairesOther: Log-bookOther: Urine sample

Interventions

HEPA air purifierDEVICE

air purifiers to remove PM and volatile organic compounds will be placed in drivers cars

Intervention GroupWait-list Control Group
questionnairesBEHAVIORAL
Intervention GroupWait-list Control Group
Log-bookOTHER

PM and biological measurements

Intervention GroupWait-list Control Group
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

Intervention GroupWait-list Control Group

Eligibility Criteria

Age21 Years - 90 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Results Point of Contact

Title
Dr. Jennifer Leng, MD, MPH
Organization
Memorial Sloan Kettering Cancer Center
lengj@mskcc.org
646-888-8057

Study Officials

  • Jennifer Leng, MD, MPH

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2015

First Posted

March 6, 2015

Study Start

December 1, 2014

Primary Completion

October 18, 2020

Study Completion

October 18, 2020

Last Updated

October 5, 2021

Results First Posted

October 5, 2021

Record last verified: 2021-02

Locations

US(1)