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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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ClinicalTrials.gov Identifier: NCT04854187
Recruitment Status : Recruiting
First Posted : April 22, 2021
Last Update Posted : April 27, 2021
Sponsor:
Collaborator:
Indian Institute of Technology Kanpur
Information provided by (Responsible Party):
Medstar Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Pollution; Exposure HTN Diabetes Mellitus Device: N95 Mask/Indoor air purifier: Including sham Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Prospective, randomized cross over study
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Personal Protective Aids on Hypertension and Diabetes in People Exposed to High Levels of Air Pollution
Actual Study Start Date : March 25, 2021
Estimated Primary Completion Date : March 25, 2022
Estimated Study Completion Date : March 25, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Air Pollution

Arm Intervention/treatment
Active Comparator: Intervention Arm - Indoor air purifier and N95 mask
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.
Device: N95 Mask/Indoor air purifier: Including sham
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.

No Intervention: Washout period - No intervention
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.
Sham Comparator: Controlled Arm - Indoor air purifier and N95 mask with sham filter
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.
Device: N95 Mask/Indoor air purifier: Including sham
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 Measures :
  1. Absolute change in systolic blood pressure for people with hypertension using air purifier and facemask [ Time Frame: 4 weeks ]
    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.

  2. Absolute change in fasting blood glucose for people with diabetes using air purifier and facemask [ Time Frame: 4 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04854187


Contacts
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Contact: Dweep Barbhaya, MBBS 2026044161 dweepbarbhaya@gmail.com

Locations
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India
Sehat Charitable trust Recruiting
Dalkhola, West Bengal, India, 733201
Contact: Manoj Khetan    9547284149    dweepbarbhaya@yahoo.in   
Principal Investigator: Aditya Khetan, MD         
Sub-Investigator: Supreme Jain         
Sub-Investigator: Anubha Goel         
Sub-Investigator: Jennifer Tran, MD         
Sub-Investigator: Chee Chan, MD         
Sponsors and Collaborators
Medstar Health Research Institute
Indian Institute of Technology Kanpur
Investigators
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Principal Investigator: Dweep Barbhaya, MD Medstar Washington Hospital Center
Principal Investigator: Aditya Khetan, MD Hamilton Health Sciences, McMaster University, Hamilton, Canada
  Study Documents (Full-Text)

Documents provided by Medstar Health Research Institute:
Informed Consent Form  [PDF] January 1, 2021

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Responsible Party: Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT04854187    
Other Study ID Numbers: IITK/IEC/2020-21/II/31
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medstar Health Research Institute:
Air pollution
HTN
DM
N95 mask
Indoor air purifier
Additional relevant MeSH terms:
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Hypertension
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases