- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07477834
Assessing the Health Impact of Indoor Air Purification Using Health Data Obtained From Apple Watch Wearers
Study Overview
Status
Intervention / Treatment
Detailed Description
Fine particulate matter (PM2.5) poses significant health risks. While indoor air purification is a proven mitigation approach, most studies have used medical devices with limited usability and practicality. Thus, this study aims to use the Apple Watch health metrics to assess short-term physiological responses in a randomized, double-blind, crossover real-world indoor purification intervention with the IQAir Atem X, the first of its kind in the UAE.
The study aims to recruit 42 healthy, non-smoking young adults to undergo two 2-week interventions (real and sham filters), separated by a 1-week washout, at the New York University Abu Dhabi campus. Collected Apple Watch metrics include: heart rate, heart rate variability, daily resting heart rate, sleep respiratory rate, blood oxygen saturation, and sleep stages durations. Daily time-location surveys enable personal PM2.5 exposure estimation from fixed-site sensors. Physiological outcomes and their associations with filtration and PM2.5 exposure are analyzed with paired tests and linear mixed-effect regression models.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Abu Dhabi, United Arab Emirates
- New York University Abu Dhabi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Own an Apple Watch Series 6 or above
- Own an iPhone
- iPhone and Apple Watch updated to the latest software versions (iOS 18 and watchOS 11, as of January 2025) to ensure consistent and latest algorithms for measuring health
- Age range: 18 - 40
- Non-smoker, defined as never smoke in life or have stopped smoking for at least one year before the start of the study
Exclusion Criteria:
- Own a Apple Watch sold by Apple in the United States on or after January 18, 2024 which does not support SpO2 measurements. These are indicated with part numbers ending in LW/A.
- Own or currently use an air quality monitor that can measure particulate matter
- Own or currently use an air purifier (humidifier or scent diffuser is fine)
- Any known pre-existing conditions: asthma, diabetes, obesity (BMI > 30), or chronic cardiorespiratory disease
- Taking any medications that might affect the heart and lung function
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Real filtration first, followed by sham filtration
Participants were randomly assigned to begin with either the real filter or sham filter, before switching halfway into the study.
This group first received real air filtration for 2 weeks, followed by a 1-week washout period, and then 2 weeks of sham filtration.
|
IQAir Atem X purifier with real filter (HyperHEPA) which is designed to remove PM2.5
IQAir Atem X purifier with sham filter which does not filter any PM2.5.
When installed inside the purifiers, the sham filter produced the same appearance and sound as the real one, making the two interventions indistinguishable to participants.
|
|
Placebo Comparator: Sham filtration first, followed by active filtration
Participants were randomly assigned to begin with either the real filter or sham filter, before switching halfway into the study.
This group first received sham filtration for 2 weeks, followed by a 1-week washout period, and then 2 weeks of real filtration.
|
IQAir Atem X purifier with real filter (HyperHEPA) which is designed to remove PM2.5
IQAir Atem X purifier with sham filter which does not filter any PM2.5.
When installed inside the purifiers, the sham filter produced the same appearance and sound as the real one, making the two interventions indistinguishable to participants.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate Changes
Time Frame: During each 2-week intervention (real and sham filtration); 1-week washout period is excluded
|
Instantaneous heart rate is measured by the Apple Watch in the background throughout the two interventions. Values are compared between the real and sham filtration to assess the effect of air purification. Unit: number of heartbeats per minute |
During each 2-week intervention (real and sham filtration); 1-week washout period is excluded
|
|
Daily Resting Heart Rate Changes
Time Frame: During each 2-week intervention (real and sham filtration); 1-week washout period is excluded
|
Resting heart rate is the daily average heart rate during rest measured by the Apple Watch in the background, reported by the Apple Watch as one single aggregated value per day, throughout the two interventions. Values are compared between the real and sham filtration to assess the effect of air purification. Unit: number of heartbeats per minute |
During each 2-week intervention (real and sham filtration); 1-week washout period is excluded
|
|
Heart Rate Variability Changes
Time Frame: During each 2-week intervention (real and sham filtration); 1-week washout period is excluded
|
Heart rate variability, variation in time between consecutive heartbeats, is measured by the Apple Watch in the background throughout the two interventions. The Apple Watch specifically measures the Standard Deviation of NN intervals (SDNN). Values are compared between the real and sham filtration to assess the effect of air purification. Unit: millisecond |
During each 2-week intervention (real and sham filtration); 1-week washout period is excluded
|
|
Oxygen Saturation Changes
Time Frame: During each 2-week intervention (real and sham filtration); 1-week washout period is excluded
|
Percentage of blood oxygen saturation is measured by the Apple Watch in the background throughout the two interventions. Values are compared between the real and sham filtration to assess the effect of air purification. Unit: % |
During each 2-week intervention (real and sham filtration); 1-week washout period is excluded
|
|
Sleep Respiratory Rate Changes
Time Frame: During each 2-week intervention (real and sham filtration); 1-week washout period is excluded
|
Respiratory rate is measured by the Apple Watch in the background during sleep throughout the two interventions. Values are compared between the real and sham filtration to assess the effect of air purification. Unit: number of breaths per minute |
During each 2-week intervention (real and sham filtration); 1-week washout period is excluded
|
|
Sleep Stages Durations Changes
Time Frame: During each 2-week intervention (real and sham filtration); 1-week washout period is excluded
|
Nightly duration of sleep stages (Core, Deep, REM, and Awake) is calculated by summing individual sleep samples and their respective timestamps as measured by the Apple Watch in the background during sleep throughout the interventions. Values are compared between the real and sham filtration to assess the effect of air purification. Unit: hour |
During each 2-week intervention (real and sham filtration); 1-week washout period is excluded
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HRPP-2024-148
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sleep
-
University of Wisconsin, MadisonPhilips HealthcareCompletedSleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization
-
Brain Electrophysiology Laboratory CompanyRecruiting
-
University GhentEuropean CommissionCompleted
-
Mahidol UniversityRamathibodi HospitalNot yet recruitingSleep Inertia | Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization | Night Shift WorkThailand
-
Northumbria UniversityCompletedSleep | Mood | Poor Quality Sleep | Good Sleep HabitUnited Kingdom
-
Universidade Federal de PernambucoEnrolling by invitationSleep | Obstructive Sleep Apnea (OSA)Brazil
-
Atlas UniversityCompletedSleep | Surgery | Sleep QualityTurkey (Türkiye)
-
Mersin UniversityCompletedSleep Quality | Sleep PerceptionTurkey (Türkiye)
-
Brigham and Women's HospitalNot yet recruitingObstructive Sleep Apnea | Sleep-disordered BreathingUnited States
-
Institute of Nutrition, Slovenia (Nutris)Valens Int. d.o.o., Slovenija; Faculty of Pharmacy, University of Ljubljana... and other collaboratorsNot yet recruitingSleep Quality | Sleep Onset LatencySlovenia
Clinical Trials on Real Filtration
-
University of Southern CaliforniaDuke University; National Institute of Environmental Health Sciences (NIEHS)RecruitingAtherosclerosis | Air PollutionUnited States
-
UConn HealthTufts University; National Institute of Environmental Health Sciences (NIEHS); Somerville Transportation Equity Partnership, Inc... and other collaboratorsCompletedBlood Pressure | Cardiovascular Risk FactorUnited States
-
University Hospital Hradec KraloveUnknownAge Related Macular DegenerationCzech Republic
-
Michigan State UniversityUniversity of MichiganCompletedCardiovascular Diseases in Old Age
-
Apheresis Research InstituteCompletedDry Age Related Macular DegenerationGermany
-
Gruppo Italiano per la Valutazione degli Interventi...BELLCO S.r.l., Mirandola (MO), ITALYTerminated
-
National Institute of Allergy and Infectious Diseases...National Heart, Lung, and Blood Institute (NHLBI); Health Resources and Services...CompletedKidney Transplantation | Kidney Failure | Kidney DonationUnited States
-
EpicentreBoston University; University of FloridaCompleted
-
Tufts UniversityCompleted