Pollution; ExposureNCT03894995
Optimizing Ventilation to Improve Health
A study testing Installation of ventilation in people with Pollution; Exposure, run by Stanford University at 1 site in Bangladesh.
Trial summary
Our overall goal is to optimize preferred, ventilating windows/apertures/vents in low-income neighborhoods of Dhaka, Bangladesh. We will: I. Collect baseline data on housing types and finalize windows/vents protoypes. II. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pollution; Exposure
- What is being tested?
- Installation of ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteBangladesh
- Study dates
- 19 Jun 2018to 30 Jun 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1) lack cross-ventilation at the time of enrollment
- 2) have obtained landlord permission to make adjustments to their dwelling,
- 3) have a free roof where a window can be installed
Who cannot join
- 1) Household reports receiving dust from nearby machine that pulverizes materials for making roads
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, 1212
About this study
Official title: Optimizing Windows to Improve Ventilation in Dhaka Slums
Our overall goal is to optimize preferred, ventilating windows/apertures/vents in low-income neighborhoods of Dhaka, Bangladesh. We will:
- Collect baseline data on housing types and finalize windows/vents protoypes.
II. Measure the impact of improved ventilation on air exchange rates in houses in low-income neighborhoods of Dhaka and characterize the current and potential market for windows/vents in households in low-income neighborhoods of Dhaka, Bangladesh.
III. Understand recipients' (tenants and landords) perceived benefits of installed window/vent designs and difficulties faced with adoption of each design
- Conditions
- Pollution; Exposure
- Being tested
- Installation of ventilation
- Keywords
- Ventilation
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Installation of ventilationOther
The intervention is installation of a ventilating structure, in this case a window in the house roof.
| Study group | Role | What they receive |
|---|---|---|
| Part 1. Focus group discussions on ventilation preferences | No intervention | Participant's perceived benefits/detriments of having ventilation options in the household and their opinions on the behavior change material developed to encourage increased household ventilation will be explored using 6-9 focus group discussions with 10-12 participants each. |
| Part 2. PM 2.5 pilot | No intervention | Indoor, outdoor, and personal particulate matter concentrations among ten mother-child pairs and their homes will be monitored. |
| Part 3. Intervention | Experimental | Households will participate in a baseline survey and a Beck-DeGroot-Marshak auction to establish willingness-to-pay for ventilation. If the household wins, or if it is decided to install ventilation in all intervention households, the household will receive installation of a ventilating mechanism. Receives: Other: Installation of ventilation |
| Part 3. Control | No intervention | For 12 month after intervention, the air exchange rate will be measured in all control households. |
| Part 4. Spillover | No intervention | Households that neighbor enrolled study households will be surveyed and asked whether they, on their own, chose to install a window. If they did install a window, they will be asked how much they paid. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Household air exchange rate - spring (Part 3)
Repeated household measurements of effective point ventilation to approximate air exchange rates in both treatment and control households will be obtained. Air exchange rates will be reported as air changes per hour for the home as well as liters of air per cubic meter per second per person.
Measured: 50 minutes
Household air exchange rate - summer (Part 3)
Repeated household measurements of effective point ventilation to approximate air exchange rates in both treatment and control households will be obtained. Air exchange rates will be reported as air changes per hour for the home as well as liters of air per cubic meter per second per person.
Measured: 50 minutes
Household air exchange rate - fall (Part 3)
Repeated household measurements of effective point ventilation to approximate air exchange rates in both treatment and control households will be obtained. Air exchange rates will be reported as air changes per hour for the home as well as liters of air per cubic meter per second per person.
Measured: 50 minutes
Household air exchange rate - winter (Part 3)
Repeated household measurements of effective point ventilation to approximate air exchange rates in both treatment and control households will be obtained. Air exchange rates will be reported as air changes per hour for the home as well as liters of air per cubic meter per second per person.
Measured: 50 minutes
Number of households that adopt the intervention (Part 3)
Takeup of the intervention will be defined by whether a household had a ventilation design installed, either by winning the BDM auction paying the full price or by accepting a free installation after previously losing the BDM auction.
Measured: 20 minutes
Revealed willingness-to-pay for ventilation (Part 3)
We will obtain stated willingness-to-pay for the ventilation designs through the BDM auction mechanism, which will be used to trace out a demand curve for ventilation, plotting the number of households that are willing to pay for a window agaist their stated price.
Measured: 20 minutes
Concentration of radon gas in house (Part 3)
We will assess the concentration gas in a subset of study households.
Measured: 7 days
Concentration of indoor particulate matter 2.5 (Part 3)
We will determine the indoor PM2.5 levels in study households, as well as the number of hours with indoor PM2.5 exceeding 50 and 100 µg/m3 during the observation period. A subset of households will have longer tests for quality control.
Measured: 48 hours for normal tests; 72 hours for quality control tests.
Concentration of indoor particulate matter 2.5 (Part 2)
We will determine the indoor PM2.5 levels in study households, as well as the number of hours with indoor PM2.5 exceeding 50 and 100 µg/m3 during the observation period.
Measured: up to 5 hours
Concentration of outdoor particulate matter 2.5 (Part 2)
We will determine the outdoor PM2.5 levels near the study households.
Measured: up to 5 hours
Personal exposure to particulate matter 2.5 - mother (Part 2)
We will determine the PM2.5 levels near the mother using a monitor worn on her body.
Measured: up to 5 hours
Personal exposure to particulate matter 2.5 - child (Part 2)
We will determine the PM2.5 levels near the child using a monitor worn on her body.
Measured: up to 5 hours
Number of non-study, neighboring households that adopt the intervention and their willingness to pay (Part 4)
We will survey households that neighbor enrolled study households to ask if they have installed a window on their own since the enrollment for the randomized control trial. If they did install a window, we will ask how much they paid.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start19 Jun 2018
- Primary completion1 Nov 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pollution; ExposureStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Johns Hopkins University, University at Buffalo
- Responsible party
- Principal investigator, Stephen P Luby, Stanford University
- Investigators
- Stephen P Luby, Dr., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894995
- Sponsor's protocol ID
- 46212
- Status last verified
- Oct 2022
- First submitted
- 27 Mar 2019
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Windows to Improve Ventilation in Dhaka Slums
- ClinicalTrials.gov ID
- NCT03894995
- Acronym / sponsor ID
- 46212
- Conditions
- Pollution; Exposure
- Keywords
- Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Johns Hopkins University, University at Buffalo
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 29 Mar 2019 (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.
Our overall goal is to optimize preferred, ventilating windows/apertures/vents in low-income neighborhoods of Dhaka, Bangladesh. We will:
- Collect baseline data on housing types and finalize windows/vents protoypes.
II. Measure the impact of improved ventilation on air exchange rates in houses in low-income neighborhoods of Dhaka and characterize the current and potential market for windows/vents in households in low-income neighborhoods of Dhaka, Bangladesh.
III. Understand recipients' (tenants and landords) perceived benefits of installed window/vent designs and difficulties faced with adoption of each design
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1. Focus group discussions on ventilation preferences | No intervention | –Participant's perceived benefits/detriments of having ventilation options in the household and their opinions on the behavior change material developed to encourage increased household ventilation will be explored using 6-9 focus group discussions with 10-12 participants each. |
| Part 2. PM 2.5 pilot | No intervention | –Indoor, outdoor, and personal particulate matter concentrations among ten mother-child pairs and their homes will be monitored. |
| Part 3. Intervention | Experimental | Other: Installation of ventilationHouseholds will participate in a baseline survey and a Beck-DeGroot-Marshak auction to establish willingness-to-pay for ventilation. If the household wins, or if it is decided to install ventilation in all intervention households, the household will receive installation of a ventilating mechanism. |
| Part 3. Control | No intervention | –For 12 month after intervention, the air exchange rate will be measured in all control households. |
| Part 4. Spillover | No intervention | –Households that neighbor enrolled study households will be surveyed and asked whether they, on their own, chose to install a window. If they did install a window, they will be asked how much they paid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1) lack cross-ventilation at the time of enrollment
- 2) have obtained landlord permission to make adjustments to their dwelling,
- 3) have a free roof where a window can be installed
Key exclusion criteria (1 listed)
- 1) Household reports receiving dust from nearby machine that pulverizes materials for making roads
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 |
|---|---|---|
| Installation of ventilationThe intervention is installation of a ventilating structure, in this case a window in the house roof. | Other | Part 3. Intervention |
Primary outcome
Household air exchange rate - spring (Part 3)
Time frame: 50 minutes
Repeated household measurements of effective point ventilation to approximate air exchange rates in both treatment and control households will be obtained. Air exchange rates will be reported as air changes per hour for the home as well as liters of air per cubic meter per second per person.
Household air exchange rate - summer (Part 3)
Time frame: 50 minutes
Repeated household measurements of effective point ventilation to approximate air exchange rates in both treatment and control households will be obtained. Air exchange rates will be reported as air changes per hour for the home as well as liters of air per cubic meter per second per person.
Household air exchange rate - fall (Part 3)
Time frame: 50 minutes
Repeated household measurements of effective point ventilation to approximate air exchange rates in both treatment and control households will be obtained. Air exchange rates will be reported as air changes per hour for the home as well as liters of air per cubic meter per second per person.
Household air exchange rate - winter (Part 3)
Time frame: 50 minutes
Repeated household measurements of effective point ventilation to approximate air exchange rates in both treatment and control households will be obtained. Air exchange rates will be reported as air changes per hour for the home as well as liters of air per cubic meter per second per person.
Number of households that adopt the intervention (Part 3)
Time frame: 20 minutes
Takeup of the intervention will be defined by whether a household had a ventilation design installed, either by winning the BDM auction paying the full price or by accepting a free installation after previously losing the BDM auction.
Revealed willingness-to-pay for ventilation (Part 3)
Time frame: 20 minutes
We will obtain stated willingness-to-pay for the ventilation designs through the BDM auction mechanism, which will be used to trace out a demand curve for ventilation, plotting the number of households that are willing to pay for a window agaist their stated price.
Concentration of radon gas in house (Part 3)
Time frame: 7 days
We will assess the concentration gas in a subset of study households.
Concentration of indoor particulate matter 2.5 (Part 3)
Time frame: 48 hours for normal tests; 72 hours for quality control tests.
We will determine the indoor PM2.5 levels in study households, as well as the number of hours with indoor PM2.5 exceeding 50 and 100 µg/m3 during the observation period. A subset of households will have longer tests for quality control.
Concentration of indoor particulate matter 2.5 (Part 2)
Time frame: up to 5 hours
We will determine the indoor PM2.5 levels in study households, as well as the number of hours with indoor PM2.5 exceeding 50 and 100 µg/m3 during the observation period.
Concentration of outdoor particulate matter 2.5 (Part 2)
Time frame: up to 5 hours
We will determine the outdoor PM2.5 levels near the study households.
Personal exposure to particulate matter 2.5 - mother (Part 2)
Time frame: up to 5 hours
We will determine the PM2.5 levels near the mother using a monitor worn on her body.
Personal exposure to particulate matter 2.5 - child (Part 2)
Time frame: up to 5 hours
We will determine the PM2.5 levels near the child using a monitor worn on her body.
Number of non-study, neighboring households that adopt the intervention and their willingness to pay (Part 4)
Time frame: 15 minutes
We will survey households that neighbor enrolled study households to ask if they have installed a window on their own since the enrollment for the randomized control trial. If they did install a window, we will ask how much they paid.
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 12 Oct 2022.
- 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.
Stephen P Luby, Dr. principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Installation of ventilation in people with Pollution; Exposure, run by Stanford University at 1 site in Bangladesh.
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 3 inclusion and 1 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 12 Oct 2022. 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 Bangladesh. 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?
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?
Household air exchange rate - spring (Part 3) (time frame: 50 minutes). The study lists 13 primary outcomes in all. 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 12 Oct 2022.