Environmental ExposureNCT05416281
Customized Approaches for Evaluating and Reducing Chemical Exposures From Home Building Materials
A study testing Robotic Vacuum in people with Environmental Exposure, run by Duke University at 1 site in United States.
Trial summary
This project will evaluate new approaches to quantify and reduce chemical exposures from common building materials, with an emphasis on plastic additives, pesticides, flame retardants and lead in addition to other environmental contaminants. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Environmental Exposure
- What is being tested?
- Robotic Vacuum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2022to 11 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants enrolled in Project HOPE 1000, a pregnancy cohort study at Duke University Medical Center.
- Any enrolled HOPE 1000 participants planning to remain in their homes for at least the following 12 weeks will be eligible for our sub-studies.
Who cannot join
- Individuals not planning to remain in their homes for at least 12 weeks.
- Those not able to communicate in fluent English will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
This project will evaluate new approaches to quantify and reduce chemical exposures from common building materials, with an emphasis on plastic additives, pesticides, flame retardants and lead in addition to other environmental contaminants. The objective of this project is to develop methods to quantify and reduce chemical exposures from the home environment using approaches that are adaptable and customizable to individuals and households. To achieve this goal investigators will: 1) Identify the types of building materials and housing characteristics associated with higher levels of exposure to different classes of contaminants; 2) Assess the effectiveness of a simple robotic vacuuming intervention for reducing exposure to a range of indoor contaminants; and 3) Evaluate a new wearable silicone wristband for monitoring exposure to lead and other metals.
Read the detailed description
This study will leverage Project HOPE 1000 (Duke University Health System IRB Pro00100000), an existing longitudinal pregnancy cohort study. Investigators will invite a subset of women participating in HOPE 1000 (n=150) to participate in an environmental assessment involving home visits by a research team. Separate informed consent will be obtained from all participants. During home visits, environmental samples will be collected (e.g. dust and water) and participants will complete a questionnaire. A smaller subset of participants (n=50) will be asked to wear a silicone wristband to monitor ambient exposure to metals. Finally, to evaluate whether robotic vacuums can reduce exposure to environmental chemicals in the home, investigators will deploy robotic vacuum cleaners (i.e., Roomba) in 50 participants' homes. Investigators will measure a range of environmental contaminants and chemicals in environmental samples. This information will be combined with data and samples collected under the HOPE 1000 protocol. In particular, investigators will analyze maternal blood samples which have already been banked for metals and will analyze previously collected silicone wristbands for the same environmental chemicals targeted in previously collected samples.
Investigators will evaluate statistical associations between contaminants in the home and occupants' exposure. Investigators will also investigate changes in exposure before and after the intervention program. Risk to study participants includes the potential loss of confidentiality.
- Conditions
- Environmental Exposure
- Being tested
- Robotic Vacuum
- Keywords
- Environmental Exposure, Vacuum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic VacuumOther
Participants will be provided with a Roomba iRobot vacuum and will be asked to use the vacuum in their home for 8 weeks. Exposure to environmental exposures will be evaluated before and after the intervention using silicone wristbands.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Vacuum Intervention | Experimental | This will include a home visit for environmental assessment AND a robotic vacuum intervention. Silicone wristbands will be used to evaluate exposure before and after a cleaning intervention. Receives: Other: Robotic Vacuum |
| No Intervention | No intervention | This will include a home visit for environmental assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Environmental Chemical Exposures
Change in the mass of environmental chemicals on silicone wristbands will be evaluated after an 8-week vacuum intervention.
Measured: Participation will last through study completion, an average of 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start11 Aug 2022
- Primary completion11 Oct 2024
- Study completion11 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Environmental ExposureStudies of the same condition, open and under way.
- More trials run by Duke 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Exposure will be evaluated before vacuuming and again after 8 weeks of vacuuming.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Stapleton, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416281
- Sponsor's protocol ID
- Pro00110402
- Status last verified
- Jul 2024
- First submitted
- 5 Jun 2022
- Last updated
- 18 Nov 2024
- 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 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Customized Approaches for Evaluating and Reducing Chemical Exposures From Home Building Materials
- ClinicalTrials.gov ID
- NCT05416281
- Acronym / sponsor ID
- Pro00110402
- Conditions
- Environmental Exposure
- Keywords
- Environmental Exposure, Vacuum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 11 Oct 2024 (actual)
- Study completion
- 11 Oct 2024 (actual)
- First posted
- 13 Jun 2022 (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 project will evaluate new approaches to quantify and reduce chemical exposures from common building materials, with an emphasis on plastic additives, pesticides, flame retardants and lead in addition to other environmental contaminants. The objective of this project is to develop methods to quantify and reduce chemical exposures from the home environment using approaches that are adaptable and customizable to individuals and households. To achieve this goal investigators will: 1) Identify the types of building materials and housing characteristics associated with higher levels of exposure to different classes of contaminants; 2) Assess the effectiveness of a simple robotic vacuuming intervention for reducing exposure to a range of indoor contaminants; and 3) Evaluate a new wearable silicone wristband for monitoring exposure to lead and other metals.
Detailed description
This study will leverage Project HOPE 1000 (Duke University Health System IRB Pro00100000), an existing longitudinal pregnancy cohort study. Investigators will invite a subset of women participating in HOPE 1000 (n=150) to participate in an environmental assessment involving home visits by a research team. Separate informed consent will be obtained from all participants. During home visits, environmental samples will be collected (e.g. dust and water) and participants will complete a questionnaire. A smaller subset of participants (n=50) will be asked to wear a silicone wristband to monitor ambient exposure to metals. Finally, to evaluate whether robotic vacuums can reduce exposure to environmental chemicals in the home, investigators will deploy robotic vacuum cleaners (i.e., Roomba) in 50 participants' homes. Investigators will measure a range of environmental contaminants and chemicals in environmental samples. This information will be combined with data and samples collected under the HOPE 1000 protocol. In particular, investigators will analyze maternal blood samples which have already been banked for metals and will analyze previously collected silicone wristbands for the same environmental chemicals targeted in previously collected samples.
Investigators will evaluate statistical associations between contaminants in the home and occupants' exposure. Investigators will also investigate changes in exposure before and after the intervention program. Risk to study participants includes the potential loss of confidentiality.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Exposure will be evaluated before vacuuming and again after 8 weeks of vacuuming.
| Arm | Type | Receives |
|---|---|---|
| Robotic Vacuum Intervention | Experimental | Other: Robotic VacuumThis will include a home visit for environmental assessment AND a robotic vacuum intervention. Silicone wristbands will be used to evaluate exposure before and after a cleaning intervention. |
| No Intervention | No intervention | –This will include a home visit for environmental assessment. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Participants enrolled in Project HOPE 1000, a pregnancy cohort study at Duke University Medical Center.
- Any enrolled HOPE 1000 participants planning to remain in their homes for at least the following 12 weeks will be eligible for our sub-studies.
Key exclusion criteria (2 listed)
- Individuals not planning to remain in their homes for at least 12 weeks.
- Those not able to communicate in fluent English will be excluded.
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 |
|---|---|---|
| Robotic VacuumParticipants will be provided with a Roomba iRobot vacuum and will be asked to use the vacuum in their home for 8 weeks. Exposure to environmental exposures will be evaluated before and after the intervention using silicone wristbands. | Other | Robotic Vacuum Intervention |
Primary outcome
Change in Environmental Chemical Exposures
Time frame: Participation will last through study completion, an average of 9 weeks
Change in the mass of environmental chemicals on silicone wristbands will be evaluated after an 8-week vacuum intervention.
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 18 Nov 2024.
- 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.
Heather Stapleton, PhD principal investigator
Duke 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 Robotic Vacuum in people with Environmental Exposure, run by Duke University at 1 site in United States.
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 2 inclusion and 2 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 18 Nov 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 United States. 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?
Change in Environmental Chemical Exposures (time frame: Participation will last through study completion, an average of 9 weeks). 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 18 Nov 2024.