Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
160 participants
INTERVENTIONAL
2023-12-26
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Active Portable Air Cleaner (PAC) Filtration
High Efficiency Particulate Air (HEPA) filter will be left intact in the PAC for 4 weeks.
PAC with HEPA filter intact
A commercially available PAC with a true HEPA filter will be used. Unit will be placed in the bedroom and used continuously (24 hours/day) for a total of 4 weeks.
Sham Portable Air Cleaner (PAC) Filtration
High Efficiency Particulate Air (HEPA) filter will be removed from the PAC for 4 weeks.
PAC with HEPA filter removed
Uses the same model as the experimental PAC that is identical in appearance and sound with the HEPA filter removed . Unit will be placed in the bedroom and used continuously (24 hours/day) for a total of 4 weeks.
Interventions
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PAC with HEPA filter intact
A commercially available PAC with a true HEPA filter will be used. Unit will be placed in the bedroom and used continuously (24 hours/day) for a total of 4 weeks.
PAC with HEPA filter removed
Uses the same model as the experimental PAC that is identical in appearance and sound with the HEPA filter removed . Unit will be placed in the bedroom and used continuously (24 hours/day) for a total of 4 weeks.
Eligibility Criteria
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Inclusion Criteria
* Participant and members of household are reported to be non-smokers (defined as no household members are currently known to smoke cigarettes or use other tobacco products including e-cigarettes)
* Participant is to understand/speak English or Spanish
* Participant can understand study procedures and give informed consent
* Participant has prediabetes, defined as the absence of diabetes and any of the following: fasting plasma glucose 100-125 mg/dL, 2 hour plasma glucose of 140-199 mg/dL after 75 g oral glucose tolerance test, or A1c 5.7- 6.4%.
* Able to wear CGM for 2 two-week periods
* Able to participate in telephone or video conference for home equipment setup if needed
* Able to visit clinic for blood draws before and after the study period
* Do not intend to sleep anywhere outside of primary bedroom for more than 48 consecutive hours or a total of 7 days during the study period.
* Ability to lift, or access to assistance with lifting, 20 lb to set up air filter appliance in bedroom.
* Have not undergone major dietary change (such as change from usual diet to intermittent fasting or caloric restriction) in the past 2 weeks, and do not intend to during the study period
Exclusion Criteria
* Participants with known atherosclerotic disease: coronary artery disease, peripheral artery disease or history of cerebrovascular disease (stroke or Transient Ischemic Attack (TIA), carotid stenosis)
* Participants with known systemic inflammatory conditions (including but not limited to: inflammatory arthritis, vasculitides, inflammatory bowel diseases, cancer within past 5 years, Hashimoto's thyroiditis)
* Participants currently taking any anti-inflammatory medications or medications that target inflammatory cytokines
* Pregnancy: because blood glucose problems during pregnancy require intensive monitoring and lifestyle changes to protect the mother and fetus
* Participants with known or suspected Covid-19 in the prior 30 days
* Participants with post-covid sequelae (a.k.a "Long covid")
* Participants who are already utilizing HEPA filtration (PAC or within HVAC) in bedrooms
18 Years
85 Years
ALL
No
Sponsors
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Doris Duke Charitable Foundation
OTHER
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Jonathan Newman
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Medical Center
New York, New York, United States
Countries
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Central Contacts
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Other Identifiers
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23-00755
Identifier Type: -
Identifier Source: org_study_id