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The Effect of Personal Protective Aids on Hypertension and Diabetes in People Exposed to High Levels of Air Pollution

Primary Purpose

Pollution; Exposure, HTN, Diabetes Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
N95 Mask/Indoor air purifier: Including sham
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pollution; Exposure focused on measuring Air pollution, HTN, DM, N95 mask, Indoor air purifier

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Hypertension arm

  1. Individuals age 18-70 years old with systolic blood pressure between 130-160 mmHg, regardless of medication use
  2. Stable hypertension for the past 3 months with no medication changes
  3. No planned medication changes for the duration of the study
  4. Exposure to outdoor air pollution above a certain threshold (pollution levels will be measured using AirVeda devices)
  5. Individuals who sleep in a closed space (such as a bedroom) for minimum of 6 hours/daily.
  6. Use of gas (LPG)/electricity for cooking purposes

Diabetes arm

  1. Individuals age 18-70 years old with fasting blood glucose between 126-180 mg/dL, regardless of medication use
  2. Stable diabetes for the past 3 months with no medication changes
  3. No planned medication changes for the duration of the study
  4. Exposure to outdoor air pollution above a certain threshold (pollution levels will be measured using AirVeda devices)
  5. Individuals who sleep in a closed space (such as a bedroom) for minimum of 6 hours/daily.
  6. Use of gas (LPG)/electricity for cooking purposes

Exclusion Criteria:

  1. Unwilling to participate
  2. Unstable blood pressure and/or blood glucose level requiring frequent medication changes
  3. Individual suffering from a physical or mental illness that precludes active study participation
  4. Current smoker
  5. Planned vacation/absence from the study site
  6. Patients with life expectancy < 12 months
  7. Pregnant patients

Sites / Locations

  • Sehat Charitable trustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Sham Comparator

Arm Label

Intervention Arm - Indoor air purifier and N95 mask

Washout period - No intervention

Controlled Arm - Indoor air purifier and N95 mask with sham filter

Arm Description

Intervention arm will be for 4 weeks. Blood pressure and/or blood glucose will be recorded on day 0; end of week 2 and end of the intervention. Participants in the intervention group will be asked to use an indoor air purifier (Atlanta Healthcare 7-Stage 43-Watt Air Purifier) daily for 4 weeks between the hours of ¬8 PM and 8 AM. The purifier will be placed in their bedroom or in the room where participants sleep at night. When the participants are outdoors (commuting, working outdoors, running errands, etc.), they will be asked to use a N95 mask (PureMe Reusable N95 Anti-Pollution Mask). It is a reusable mask which can be washed by the participants. Every 2 weeks, the filter of the mask will be replaced, and the filter of the indoor purifier will be washed.

At the end of either control or intervention arm, participants will have a washout period of 2 weeks, after which participants will be crossed over to the other group for the subsequent 4 weeks. For example, after Participant AB is in intervention arm for 4 weeks, he/she will then have a wash out period of 2 weeks in which they will return to their usual state of living. At the end of the washout period, the participant AB will be put in the control arm for 4 weeks.

Control arm will be for 4 weeks. Blood pressure, blood glucose and indoor air pollution level will be recorded similarly as in the intervention group on day 0, end of week 2 and week 4. The participant will be provided an air purifier and a N-95 mask (of the same manufacturer), with the filter removed. At the end of two weeks, the health worker will make dummy adjustments to the mask and indoor air purifier, to maintain blinding of the participant.

Outcomes

Primary Outcome Measures

Absolute change in systolic blood pressure for people with hypertension using air purifier and facemask
We will monitor blood pressure at week 0,2,4 of both intervention and control period. Outcome would be measured as difference in the mean systolic blood pressure between both arms.
Absolute change in fasting blood glucose for people with diabetes using air purifier and facemask
We will monitor fasting blood glucose at week 0,2,4 of both intervention and control period. Outcome would be measured as difference in the mean systolic blood pressure between both arms.

Secondary Outcome Measures

Full Information

First Posted
March 30, 2021
Last Updated
May 5, 2022
Sponsor
Medstar Health Research Institute
Collaborators
Indian Institute of Technology Kanpur
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1. Study Identification

Unique Protocol Identification Number
NCT04854187
Brief Title
The Effect of Personal Protective Aids on Hypertension and Diabetes in People Exposed to High Levels of Air Pollution
Official Title
The Effect of Personal Protective Aids on Hypertension and Diabetes in People Exposed to High Levels of Air Pollution
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2021 (Actual)
Primary Completion Date
March 25, 2023 (Anticipated)
Study Completion Date
March 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medstar Health Research Institute
Collaborators
Indian Institute of Technology Kanpur

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized controlled trial to evaluate personal protective aids (air purifier and N95) as a therapeutic measure in people with hypertension and diabetes exposed to high levels of PM2.5 in India.
Detailed Description
Air pollution is the largest environmental cause of disease and premature death in the world today, disproportionally affecting low- and middle-income countries (LMICs) such as India. Numerous studies have shown that exposure to particulate matter <2.5 µm (PM2.5) can contribute to cardiovascular disease and mortality, which is partially attributable to the development of cardiometabolic conditions such as hypertension and diabetes. We hypothesize that the use of personal protective aids (home air-purifier and N-95 mask) can decrease systolic blood pressure (SBP) in people with hypertension and decrease fasting blood glucose (FBG) in those with diabetes. This is a prospective randomized cross-over study in Dalkhola, India- an area of high ambient PM2.5 levels. Participants between 18 and 70 years of age with hypertension (n=130) and diabetes (n=33) will be invited to participate in the study. They will be randomized to either an intervention or control arm for 4 weeks, after which they will cross over to the other arm following a 2-week washout period. The intervention period will consist of using an indoor air-purifier at night and an N-95 mask when outdoors. Control period will involve using an identical air purifier and facemask, with the filter removed (sham filtration). Participants and outcome assessors will be blinded. The primary outcome of the study is the absolute reduction in SBP among people with hypertension and absolute reduction in FBG among people with diabetes. This is the first randomized controlled trial to evaluate personal protective aids as a therapeutic measure in people with hypertension and diabetes exposed to high levels of PM2.5. Given the high burden of air pollution in LMICs, there is an urgent need for adaptation measures targeting people at high risk for mortality from this exposure. The results of our study will demonstrate if personal protective aids can be a viable adaptation measure for people living with hypertension and diabetes in areas with a high burden of air pollution.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pollution; Exposure, HTN, Diabetes Mellitus
Keywords
Air pollution, HTN, DM, N95 mask, Indoor air purifier

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Prospective, randomized cross over study
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm - Indoor air purifier and N95 mask
Arm Type
Active Comparator
Arm Description
Intervention arm will be for 4 weeks. Blood pressure and/or blood glucose will be recorded on day 0; end of week 2 and end of the intervention. Participants in the intervention group will be asked to use an indoor air purifier (Atlanta Healthcare 7-Stage 43-Watt Air Purifier) daily for 4 weeks between the hours of ¬8 PM and 8 AM. The purifier will be placed in their bedroom or in the room where participants sleep at night. When the participants are outdoors (commuting, working outdoors, running errands, etc.), they will be asked to use a N95 mask (PureMe Reusable N95 Anti-Pollution Mask). It is a reusable mask which can be washed by the participants. Every 2 weeks, the filter of the mask will be replaced, and the filter of the indoor purifier will be washed.
Arm Title
Washout period - No intervention
Arm Type
No Intervention
Arm Description
At the end of either control or intervention arm, participants will have a washout period of 2 weeks, after which participants will be crossed over to the other group for the subsequent 4 weeks. For example, after Participant AB is in intervention arm for 4 weeks, he/she will then have a wash out period of 2 weeks in which they will return to their usual state of living. At the end of the washout period, the participant AB will be put in the control arm for 4 weeks.
Arm Title
Controlled Arm - Indoor air purifier and N95 mask with sham filter
Arm Type
Sham Comparator
Arm Description
Control arm will be for 4 weeks. Blood pressure, blood glucose and indoor air pollution level will be recorded similarly as in the intervention group on day 0, end of week 2 and week 4. The participant will be provided an air purifier and a N-95 mask (of the same manufacturer), with the filter removed. At the end of two weeks, the health worker will make dummy adjustments to the mask and indoor air purifier, to maintain blinding of the participant.
Intervention Type
Device
Intervention Name(s)
N95 Mask/Indoor air purifier: Including sham
Intervention Description
Participants will be using indoor air purifier and N95 mask (control arm with sham filters). The effect will be studied on blood pressure and blood glucose levels.
Primary Outcome Measure Information:
Title
Absolute change in systolic blood pressure for people with hypertension using air purifier and facemask
Description
We will monitor blood pressure at week 0,2,4 of both intervention and control period. Outcome would be measured as difference in the mean systolic blood pressure between both arms.
Time Frame
4 weeks
Title
Absolute change in fasting blood glucose for people with diabetes using air purifier and facemask
Description
We will monitor fasting blood glucose at week 0,2,4 of both intervention and control period. Outcome would be measured as difference in the mean systolic blood pressure between both arms.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Hypertension arm Individuals age 18-70 years old with systolic blood pressure between 130-160 mmHg, regardless of medication use Stable hypertension for the past 3 months with no medication changes No planned medication changes for the duration of the study Exposure to outdoor air pollution above a certain threshold (pollution levels will be measured using AirVeda devices) Individuals who sleep in a closed space (such as a bedroom) for minimum of 6 hours/daily. Use of gas (LPG)/electricity for cooking purposes Diabetes arm Individuals age 18-70 years old with fasting blood glucose between 126-180 mg/dL, regardless of medication use Stable diabetes for the past 3 months with no medication changes No planned medication changes for the duration of the study Exposure to outdoor air pollution above a certain threshold (pollution levels will be measured using AirVeda devices) Individuals who sleep in a closed space (such as a bedroom) for minimum of 6 hours/daily. Use of gas (LPG)/electricity for cooking purposes Exclusion Criteria: Unwilling to participate Unstable blood pressure and/or blood glucose level requiring frequent medication changes Individual suffering from a physical or mental illness that precludes active study participation Current smoker Planned vacation/absence from the study site Patients with life expectancy < 12 months Pregnant patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dweep Barbhaya, MBBS
Phone
2026044161
Email
dweepbarbhaya@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dweep Barbhaya, MD
Organizational Affiliation
Medstar Washington Hospital Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aditya Khetan, MD
Organizational Affiliation
Hamilton Health Sciences, McMaster University, Hamilton, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sehat Charitable trust
City
Dalkhola
State/Province
West Bengal
ZIP/Postal Code
733201
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manoj Khetan
Phone
9547284149
Email
dweepbarbhaya@yahoo.in
First Name & Middle Initial & Last Name & Degree
Aditya Khetan, MD
First Name & Middle Initial & Last Name & Degree
Supreme Jain
First Name & Middle Initial & Last Name & Degree
Anubha Goel
First Name & Middle Initial & Last Name & Degree
Jennifer Tran, MD
First Name & Middle Initial & Last Name & Degree
Chee Chan, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Personal Protective Aids on Hypertension and Diabetes in People Exposed to High Levels of Air Pollution

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