Pollution; ExposureNCT04854187
The Effect of Personal Protective Aids on Hypertension and Diabetes in People Exposed to High Levels of Air Pollution
A study of Pollution; Exposure and HTN, run by Medstar Health Research Institute at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pollution; Exposure, HTN, Diabetes Mellitus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteIndia
- Study dates
- 25 Mar 2021to 17 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pollution; Exposure, HTN, Diabetes Mellitus
- Being tested
- N95 Mask/Indoor air purifier: Including sham
- Keywords
- Air pollution, HTN, DM, N95 mask, Indoor air purifier
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N95 Mask/Indoor air purifier: Including shamDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm - Indoor air purifier and N95 mask | Active comparator | 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. Receives: Device: N95 Mask/Indoor air purifier: Including sham |
| Washout period - No intervention | 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. |
| Controlled Arm - Indoor air purifier and N95 mask with sham filter | Sham comparator | 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. Receives: Device: N95 Mask/Indoor air purifier: Including sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start25 Mar 2021
- Primary completion17 Oct 2024
- Study completion17 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pollution; ExposureStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, randomized cross over study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Institute of Technology Kanpur
- Responsible party
- Sponsor
- Investigators
- Dweep Barbhaya, MD, Principal investigator, Medstar Health Research InstituteAditya Khetan, MD, Principal investigator, Hamilton Health Sciences, McMaster University, Hamilton, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854187
- Sponsor's protocol ID
- IITK/IEC/2020-21/II/31
- Status last verified
- Oct 2024
- First submitted
- 30 Mar 2021
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barbhaya D, Tran J, Khetan A, Hejjaji V, Jain S, Chan C, Goel A. Rationale and Design of a Study to Test the Effect of Personal Protective Aids on Hypertension and Diabetes in People Living With High Levels of Air Pollution-Study Protocol. Heart Lung Circ. 2023 Jan;32(1):124-130. doi: 10.1016/j.hlc.2022.11.001. Epub 2022 Dec 15.
PubMed 36528547
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Personal Protective Aids on Hypertension and Diabetes in People Exposed to High Levels of Air Pollution
- ClinicalTrials.gov ID
- NCT04854187
- Acronym / sponsor ID
- IITK/IEC/2020-21/II/31
- Conditions
- Pollution; Exposure, HTN, Diabetes Mellitus
- Keywords
- Air pollution, HTN, DM, N95 mask, Indoor air purifier
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- Indian Institute of Technology Kanpur
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 17 Oct 2024 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, randomized cross over study
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm - Indoor air purifier and N95 mask | Active comparator | Device: N95 Mask/Indoor air purifier: Including shamIntervention 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. |
| Washout period - No intervention | 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. |
| Controlled Arm - Indoor air purifier and N95 mask with sham filter | Sham comparator | Device: N95 Mask/Indoor air purifier: Including shamControl 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| N95 Mask/Indoor air purifier: Including shamParticipants 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. | Device | Controlled Arm - Indoor air purifier and N95 mask with sham filter, Intervention Arm - Indoor air purifier and N95 mask |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Derived from this study: PubMed 36528547Barbhaya D, Tran J, Khetan A, Hejjaji V, Jain S, Chan C, Goel A. Rationale and Design of a Study to Test the Effect of Personal Protective Aids on Hypertension and Diabetes in People Living With High Levels of Air Pollution-Study Protocol. Heart Lung Circ. 2023 Jan;32(1):124-130. doi: 10.1016/j.hlc.2022.11.001. Epub 2022 Dec 15.
- Individual participant dataSharing planned: No
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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.
Dweep Barbhaya, MD principal investigator
Medstar Health Research Institute
Aditya Khetan, MD principal investigator
Hamilton Health Sciences, McMaster University, Hamilton, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Pollution; Exposure and HTN, run by Medstar Health Research Institute at 1 site in India.
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 14 inclusion and 7 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 22 Oct 2024. 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 India. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Absolute change in systolic blood pressure for people with hypertension using air purifier and facemask (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04854187, which also lists 1 linked publication.
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 22 Oct 2024; AzTrials last refreshed its copy on 26 Oct 2026.