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临床试验/NCT07477834
NCT07477834已完成不适用

Assessing the Health Impact of Indoor Air Purification Using Health Data Obtained From Apple Watch Wearers

New York University Abu Dhabi1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年2月9日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
1
主要终点
Heart Rate Changes

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Real filtration first, followed by sham filtration

Experimental

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.

干预措施: Real Filtration (Behavioral)

Real filtration first, followed by sham filtration

Experimental

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.

干预措施: Sham Filtration (Behavioral)

Sham filtration first, followed by active filtration

Placebo Comparator

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.

干预措施: Real Filtration (Behavioral)

Sham filtration first, followed by active filtration

Placebo Comparator

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.

干预措施: Sham Filtration (Behavioral)

结局指标

主要结局

Heart Rate Changes

时间窗: 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

Daily Resting Heart Rate Changes

时间窗: 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

Heart Rate Variability Changes

时间窗: 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

Oxygen Saturation Changes

时间窗: 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: %

Sleep Respiratory Rate Changes

时间窗: 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

Sleep Stages Durations Changes

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
New York University Abu Dhabi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Samreen Malik

Principal Investigator

New York University Abu Dhabi

研究点 (1)

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