Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-05 @ 9:24 PM
Study NCT ID:
NCT07477834
Status:
COMPLETED
Last Update Posted:
2026-03-17
First Post:
2026-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Health Impact of Indoor Air Purification Using Health Data Obtained From Apple Watch Wearers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2026-03-12', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart Rate Changes', 'timeFrame': 'During each 2-week intervention (real and sham filtration); 1-week washout period is excluded', 'description': '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.\n\nUnit: number of heartbeats per minute'}, {'measure': 'Daily Resting Heart Rate Changes', 'timeFrame': 'During each 2-week intervention (real and sham filtration); 1-week washout period is excluded', 'description': '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.\n\nUnit: number of heartbeats per minute'}, {'measure': 'Heart Rate Variability Changes', 'timeFrame': 'During each 2-week intervention (real and sham filtration); 1-week washout period is excluded', 'description': '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.\n\nUnit: millisecond'}, {'measure': 'Oxygen Saturation Changes', 'timeFrame': 'During each 2-week intervention (real and sham filtration); 1-week washout period is excluded', 'description': '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.\n\nUnit: %'}, {'measure': 'Sleep Respiratory Rate Changes', 'timeFrame': 'During each 2-week intervention (real and sham filtration); 1-week washout period is excluded', 'description': '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.\n\nUnit: number of breaths per minute'}, {'measure': 'Sleep Stages Durations Changes', 'timeFrame': 'During each 2-week intervention (real and sham filtration); 1-week washout period is excluded', 'description': '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.\n\nUnit: hour'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Indoor Air Purification', 'Apple Watch', 'Digital Health Research'], 'conditions': ['Air Pollution Exposure', 'Heart Rate', 'Resting Heart Rate', 'HRV', 'SpO2', 'Respiratory Rate', 'Sleep']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Own an Apple Watch Series 6 or above\n* Own an iPhone\n* 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\n* Age range: 18 - 40\n* Non-smoker, defined as never smoke in life or have stopped smoking for at least one year before the start of the study\n\nExclusion Criteria:\n\n* 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.\n* Own or currently use an air quality monitor that can measure particulate matter\n* Own or currently use an air purifier (humidifier or scent diffuser is fine)\n* Any known pre-existing conditions: asthma, diabetes, obesity (BMI \\> 30), or chronic cardiorespiratory disease\n* Taking any medications that might affect the heart and lung function'}, 'identificationModule': {'nctId': 'NCT07477834', 'briefTitle': 'Assessing the Health Impact of Indoor Air Purification Using Health Data Obtained From Apple Watch Wearers', 'organization': {'class': 'OTHER', 'fullName': 'New York University Abu Dhabi'}, 'officialTitle': 'Assessing the Health Impact of Indoor Air Purification Using Health Data Obtained From Apple Watch Wearers', 'orgStudyIdInfo': {'id': 'HRPP-2024-148'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Real filtration first, followed by sham filtration', 'description': '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.', 'interventionNames': ['Behavioral: Real Filtration', 'Behavioral: Sham Filtration']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sham filtration first, followed by active filtration', 'description': '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.', 'interventionNames': ['Behavioral: Real Filtration', 'Behavioral: Sham Filtration']}], 'interventions': [{'name': 'Real Filtration', 'type': 'BEHAVIORAL', 'description': 'IQAir Atem X purifier with real filter (HyperHEPA) which is designed to remove PM2.5', 'armGroupLabels': ['Real filtration first, followed by sham filtration', 'Sham filtration first, followed by active filtration']}, {'name': 'Sham Filtration', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Real filtration first, followed by sham filtration', 'Sham filtration first, followed by active filtration']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Abu Dhabi', 'country': 'United Arab Emirates', 'facility': 'New York University Abu Dhabi', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York University Abu Dhabi', 'class': 'OTHER'}, 'collaborators': [{'name': 'IQAir AG', 'class': 'UNKNOWN'}, {'name': 'LUT University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Samreen Malik', 'investigatorAffiliation': 'New York University Abu Dhabi'}}}}