The Impact of Indoor Environmental Quality on Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD-AIR)
2026年8月27日 更新者：Ziekenhuis Oost-Limburg
The Impact of Indoor Environmental Quality on Symptoms in Patients With Chronic Obstructive Pulmonary Disease: A Prospective Pilot Study
This prospective, monocenter pilot study will investigate the relationship between indoor environmental quality (including air quality, lighting, noise, and thermal conditions), wearable-derived health insights, and patient-reported symptoms in patients recovering at home after hospitalization for an acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Participants will undergo continuous monitoring of indoor environmental conditions and health parameters using a Garmin Venu 4 smartwatch, together with validated questionnaires assessing COPD symptoms, sleep quality, and daytime sleepiness during one month. The study will assess the feasibility and potential added value of high-resolution home monitoring and explore whether environmental and wearable-derived measures are associated with symptom burden and early signs of clinical deterioration following hospital discharge.
The investigators hypothesize that continuous in-home monitoring of indoor environmental quality is feasible and provides clinically relevant insights into symptom burden in recently hospitalized COPD patients. The primary objective is to determine the correlation between indoor environmental quality (IEQ) variables and symptom burden in COPD patients following hospitalization for AECOPD.
研究概览
地位
尚未招聘
详细说明
Patients hospitalized for an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) remain highly vulnerable after discharge, with persistent symptom burden and an increased risk of early recurrent exacerbations. During this post-hospitalization period, patients spend most of their time indoors, making indoor environmental quality (IEQ, including air quality, lighting, noise and thermal aspects) a potentially important and modifiable determinant of recovery. For example, exposure to particulate matter (PM) has been associated with airway inflammation, symptom worsening, and increased exacerbation risk in COPD. However, evidence on continuously measured IEQ at home and its relationship with symptoms after hospitalization for acute exacerbation of COPD remains limited.
Recent advances in wearable technology allow continuous monitoring of health insights in real-world settings. Prior studies have demonstrated the feasibility of wearable devices in patients with COPD and suggest that changes in activity, heart rate, and sleep may precede clinical deterioration or exacerbations. Integrating continuous IEQ monitoring with wearable-derived health insights (i.e., from a Garmin Venu 4 watch) and validated patient-reported outcomes, such as the widely used COPD Assessment Test (CAT), Pittsburgh Sleep Quality Index (PSQI), Karolinska Sleepiness Scale (KSS), Sleep Quality Scale (SQS), may improve understanding of symptom dynamics, uncover risk factors, and identify early indicators of worsening disease. This prospective monocenter pilot study aims to explore these relationships and to assess the feasibility and added value of high-resolution IEQ monitoring in the home setting of recently hospitalized COPD patients.
研究类型
介入性
注册 (估计的)
15
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Ruben Knevels, MsC
- 电话号码：+3289804029
- 邮箱：ruben.knevels@zol.be
研究联系人备份
- 姓名：Femke Wouters, PhD
- 邮箱：femke.wouters@zol.be
学习地点
-
-
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Genk、比利时、3600
- Ziekenhuis Oost-Limburg
-
接触：
- Ruben Knevels, MsC
- 电话号码：+3289804029
- 邮箱：ruben.knevels@zol.be
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Provide signed and dated informed consent
- Adults older than 18 years of age
- Previously diagnosed with COPD according to GOLD guidelines
- Hospitalization due to AECOPD
- Spend >50% of time indoor at home
- Speak and understand the Dutch language
Exclusion Criteria:
- Previous diagnosis of asthma
- (History of) chronic macrolide use (> 3 months)
- Living in institution or residential care center
- Estimated life expectancy of less than 6 months
- Not in the possession of a smartphone
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Patients admitted with an acute COPD exacerbation
Wearable mobile device (Garmin Venu) & Indoor environmental quality sensor
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Patients admitted due to an acute COPD exacerbation will be asked to wear the wearable mobile device for a period of one month after hospital discharge.
An app linked to the device will be installed on their phone, and used to send health insights to the investigators.
其他名称：
When the participants are discharged home, an indoor environmental quality sensor will be installed in the patient's home.
One sensor will be installed in the bedroom, one in the living room or kitchen (wherever the patient spends the most time).
Data from these sensors will be sent to the hub (placed central between the sensors) and thereafter, to the investigators.
The sensors measure particulate matter concentrations, CO2 concentrations, VOC concentrations, temperature, relative humidity, ambient light, and ambient noise.
A COPD Assessment Test questionnaire will be taken during the hospitalization (start of the study), and weekly after discharge.
A Pittsburgh Sleep Quality Index questionnaire will be taken 4 weeks after hospital discharge (end of the study).
A Karolinska Sleepiness Scale questionnaire will be taken daily after discharge.
A sleep quality scale questionnaire will be taken daily after discharge.
A PROMs questionnaire will be taken daily after discharge.
An eHealth literacy questionnaire will be taken during the hospitalization (start of the study), and 4 weeks after hospital discharge (end of the study).
A housing questionnaire will be taken during the hospitalization (start of the study).
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Weekly score of COPD symptom burden assessed using the COPD Assessment Test (CAT)
大体时间：Baseline and weekly during the 1-month follow-up
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COPD symptom burden will be assessed using the COPD Assessment Test (CAT).
The CAT is an 8-item questionnaire with a total score ranging from 0 to 40 points, with higher scores indicating greater COPD symptom burden and a greater impact of COPD on daily life.
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Baseline and weekly during the 1-month follow-up
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Weekly mean PM0.5 concentration
大体时间：Weekly during the 1-month follow-up
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Indoor PM0.5 concentration (µg/m³) will be measured at 15-minute intervals in the participant's home during the 1-month follow-up.
The measurements collected during each week will be aggregated to calculate a weekly mean PM0.5 concentration.
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Weekly during the 1-month follow-up
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Weekly mean PM2.5 concentration
大体时间：Weekly during the 1-month follow-up
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Indoor PM2.5 concentration (µg/m³) will be measured at 15-minute intervals in the participant's home during the 1-month follow-up.
The measurements collected during each week will be aggregated to calculate a weekly mean PM2.5 concentration.
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Weekly during the 1-month follow-up
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Weekly mean PM4 concentration
大体时间：Weekly during the 1-month follow-up
|
Indoor PM4 concentration (µg/m³) will be measured at 15-minute intervals in the participant's home during the 1-month follow-up.
The measurements collected during each week will be aggregated to calculate a weekly mean PM4 concentration.
|
Weekly during the 1-month follow-up
|
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Weekly mean PM10 concentration
大体时间：Weekly during the 1-month follow-up
|
Indoor PM10 concentration (µg/m³) will be measured at 15-minute intervals in the participant's home during the 1-month follow-up.
The measurements collected during each week will be aggregated to calculate a weekly mean PM10 concentration.
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Weekly during the 1-month follow-up
|
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Weekly mean CO2 concentration
大体时间：Weekly during the 1-month follow-up
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Indoor CO2 concentration (ppm) will be measured at 15-minute intervals in the participant's home during the 1-month follow-up.
The measurements collected during each week will be aggregated to calculate a weekly mean CO2 concentration.
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Weekly during the 1-month follow-up
|
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Weekly mean VOC concentration
大体时间：Weekly during the 1-month follow-up
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Indoor volatile organic compound (VOC) concentration (ppb) will be measured at 15-minute intervals in the participant's home during the 1-month follow-up.
The measurements collected during each week will be aggregated to calculate a weekly mean VOC concentration.
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Weekly during the 1-month follow-up
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Weekly mean temperature
大体时间：Weekly during the 1-month follow-up
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Indoor temperature concentration (°C) will be measured at 15-minute intervals in the participant's home during the 1-month follow-up.
The measurements collected during each week will be aggregated to calculate a weekly mean temperature.
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Weekly during the 1-month follow-up
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Weekly mean relative humidity
大体时间：Weekly during the 1-month follow-up
|
Indoor relative humidity (%) will be measured at 15-minute intervals in the participant's home during the 1-month follow-up.
The measurements collected during each week will be aggregated to calculate a weekly mean relative humidity.
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Weekly during the 1-month follow-up
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Weekly mean ambient light - day
大体时间：Weekly during the 1-month follow-up
|
Indoor ambient light (lux) will be measured at 15-minute intervals in the participant's home during the 1-month follow-up.
The measurements collected during each week during day-time hours will be aggregated to calculate a weekly mean ambient light - day.
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Weekly during the 1-month follow-up
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Weekly mean ambient light - night
大体时间：Weekly during the 1-month follow-up
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Indoor ambient light (lux) will be measured at 15-minute intervals in the participant's home during the 1-month follow-up.
The measurements collected during each week during night-time hours will be aggregated to calculate a weekly mean ambient light - night.
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Weekly during the 1-month follow-up
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Weekly mean ambient noise - night
大体时间：Weekly during the 1-month follow-up
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Indoor ambient noise (dB) will be measured at 15-minute intervals in the participant's home during the 1-month follow-up.
The measurements collected during each week during night-time hours will be aggregated to calculate a weekly mean ambient noise - night.
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Weekly during the 1-month follow-up
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Weekly overall proportion of time with at least one IEQ threshold violated
大体时间：Weekly during the 1-month follow-up
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Overall proportion of monitoring time per week during which at least one predefined indoor environmental quality (IEQ) threshold is violated.
IEQ variables will be monitored at predefined measurement intervals during the 1-month follow-up.
For each measurement time point, the IEQ variables will be compared with their respective predefined thresholds.
The proportion of monitoring time points at which at least one IEQ threshold is violated will be calculated for each week.
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Weekly during the 1-month follow-up
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Feasibility - Measurement completeness
大体时间：During follow-up (1 month)
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Proportion of expected IEQ measurements successfully recorded.
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During follow-up (1 month)
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Feasibility - Valid monitoring time
大体时间：During follow-up (1 month)
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Duration of valid monitoring time per participant.
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During follow-up (1 month)
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Daily perceived change in health status
大体时间：Daily during follow-up (1 month)
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Patient-reported change in overall health status compared with the previous day, assessed using a single question: "How is your health today compared with yesterday?"
Participants will select one of three response options: better, about the same, or worse.
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Daily during follow-up (1 month)
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Feasibility - Frequency of data gaps
大体时间：During follow-up (1 month)
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Frequency of gaps in monitoring data.
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During follow-up (1 month)
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Feasibility - Duration of data gaps
大体时间：During follow-up (1 month)
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Duration of gaps in monitoring data.
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During follow-up (1 month)
|
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Wearable-derived health insights - Heart rate
大体时间：Continuous monitoring during follow-up (1 month)
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Heart rate (BPM) measured using the wearable.
|
Continuous monitoring during follow-up (1 month)
|
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Wearable-derived health insights - Respiratory rate
大体时间：Continuous monitoring during follow-up (1 month)
|
Respiratory rate (BPM) measured using the wearable.
|
Continuous monitoring during follow-up (1 month)
|
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Wearable-derived health insights - Oxygen saturation
大体时间：Continuous monitoring during follow-up (1 month)
|
Oxygen saturation (%) measured using the wearable.
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Continuous monitoring during follow-up (1 month)
|
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Wearable-derived health insights - Skin temperature
大体时间：Continuous monitoring during follow-up (1 month)
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Nightly deviation in skin temperature (°C) compared with the previous night, measured using the wearable.
|
Continuous monitoring during follow-up (1 month)
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|
Sleep quality - PSQI
大体时间：End of study (one month)
|
Pittsburgh Sleep Quality Index (PSQI) assessing subjective sleep quality over the preceding month.
The PSQI total score ranges from 0 to 21 points, with higher scores indicating poorer sleep quality.
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End of study (one month)
|
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Sleepiness - KSS
大体时间：Daily during the 1-month follow-up
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Karolinska Sleepiness Scale (KSS) assessing subjective sleepiness at a specific time point.
The KSS score ranges from 1 to 9 points, with higher scores indicating greater subjective sleepiness.
|
Daily during the 1-month follow-up
|
|
Sleep quality - SQS
大体时间：Daily during the 1-month follow-up
|
Single-item Sleep Quality Scale (SQS) assessing perceived sleep quality of the previous night.
The SQS score ranges from 0 to 10 points, with higher scores indicating better perceived sleep quality.
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Daily during the 1-month follow-up
|
|
Wearable-derived sleep metrics - Sleep duration
大体时间：Nightly during the 1-month follow-up
|
Nightly sleep duration (hours) measured using the wearable.
|
Nightly during the 1-month follow-up
|
|
Wearable-derived sleep metrics - Sleep score
大体时间：Nightly during the 1-month follow-up
|
Nightly sleep score measured using the wearable.
Score from 0-100, with a higher score indicating better quality of sleep.
|
Nightly during the 1-month follow-up
|
|
Wearable-derived sleep metrics - Time in sleep cycle
大体时间：Nightly during the 1-month follow-up
|
Nightly time spent in REM, deep, and light sleep (hours).
|
Nightly during the 1-month follow-up
|
|
Wearable-derived physical activity - Daily step count
大体时间：Daily during the 1-month follow-up
|
Daily step count (number) measured by the wearable.
|
Daily during the 1-month follow-up
|
|
Wearable-derived physical activity - Activity minutes
大体时间：Daily during the 1-month follow-up
|
Daily activity minutes (minutes) measured by the wearable.
|
Daily during the 1-month follow-up
|
|
Concentration of outside air quality
大体时间：During follow-up (1 month)
|
Concentration of outside air quality measure (PM, expressed in µg/m³) based on the participant's residential area.
|
During follow-up (1 month)
|
|
COPD exacerbations
大体时间：During follow-up (1 month)
|
Occurrence of a COPD exacerbation during the follow-up period.
|
During follow-up (1 month)
|
|
eHealth literacy
大体时间：Baseline and end of study (one month)
|
eHealth Literacy Questionnaire (eHLQ) domain scores describing participants' strengths and needs related to eHealth literacy.
The eHLQ consists of 35 items across 7 domains.
Each domain is scored from 1 to 4 points, with higher scores indicating a greater level of the characteristic assessed by the respective domain.
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Baseline and end of study (one month)
|
|
Change in eHealth literacy
大体时间：Baseline and end of study (one month)
|
Change in eHealth literacy from baseline to the end of the 1-month follow-up, assessed using the eHealth Literacy Questionnaire (eHLQ).
The eHLQ consists of 35 items across 7 domains.
Each domain is scored from 1 to 4 points.
Higher scores indicate a greater level of the characteristic assessed by the respective domain.
Change in each domain score from baseline to 1 month will be calculated.
|
Baseline and end of study (one month)
|
|
Housing characteristics
大体时间：Baseline
|
Sociodemographic characteristics, housing characteristics, and indoor environmental factors assessed using the Housing Conditions Questionnaire.
|
Baseline
|
|
Weekly overall proportion of time with PM0.5 threshold exceeded
大体时间：Weekly during the 1-month follow-up
|
Overall proportion of monitoring time per week during which PM0.5 threshold is exceeded.
PM0.5 will be monitored at predefined measurement intervals during the 1-month follow-up.
For each measurement time point, PM0.5 will be compared with its respective predefined threshold.
The proportion of monitoring time points at which PM0.5 is exceeded will be calculated for each week.
|
Weekly during the 1-month follow-up
|
|
Weekly overall proportion of time with PM1 threshold exceeded
大体时间：Weekly during the 1-month follow-up
|
Overall proportion of monitoring time per week during which PM1 threshold is exceeded.
PM1 will be monitored at predefined measurement intervals during the 1-month follow-up.
For each measurement time point, PM1 will be compared with its respective predefined threshold.
The proportion of monitoring time points at which PM1 is exceeded will be calculated for each week.
|
Weekly during the 1-month follow-up
|
|
Weekly overall proportion of time with PM2.5 threshold exceeded
大体时间：Weekly during the 1-month follow-up
|
Overall proportion of monitoring time per week during which PM2.5 threshold is exceeded.
PM2.5 will be monitored at predefined measurement intervals during the 1-month follow-up.
For each measurement time point, PM2.5 will be compared with its respective predefined threshold.
The proportion of monitoring time points at which PM2.5 is exceeded will be calculated for each week.
|
Weekly during the 1-month follow-up
|
|
Weekly overall proportion of time with PM4 threshold exceeded
大体时间：Weekly during the 1-month follow-up
|
Overall proportion of monitoring time per week during which PM4 threshold is exceeded.
PM4 will be monitored at predefined measurement intervals during the 1-month follow-up.
For each measurement time point, PM4 will be compared with its respective predefined threshold.
The proportion of monitoring time points at which PM4 is exceeded will be calculated for each week.
|
Weekly during the 1-month follow-up
|
|
Weekly overall proportion of time with PM10 threshold exceeded
大体时间：Weekly during the 1-month follow-up
|
Overall proportion of monitoring time per week during which PM10 threshold is exceeded.
PM10 will be monitored at predefined measurement intervals during the 1-month follow-up.
For each measurement time point, PM10 will be compared with its respective predefined threshold.
The proportion of monitoring time points at which PM10 is exceeded will be calculated for each week.
|
Weekly during the 1-month follow-up
|
|
Weekly overall proportion of time with CO2 threshold exceeded
大体时间：Weekly during the 1-month follow-up
|
Overall proportion of monitoring time per week during which the CO2 threshold is exceeded.
CO2 will be monitored at predefined measurement intervals during the 1-month follow-up.
For each measurement time point, CO2 will be compared with its respective predefined threshold.
The proportion of monitoring time points at which CO2 is exceeded will be calculated for each week.
|
Weekly during the 1-month follow-up
|
|
Weekly overall proportion of time with VOC threshold exceeded
大体时间：Weekly during the 1-month follow-up
|
Overall proportion of monitoring time per week during which the VOC threshold is exceeded.
VOC will be monitored at predefined measurement intervals during the 1-month follow-up.
For each measurement time point, VOC will be compared with its respective predefined threshold.
The proportion of monitoring time points at which VOC is exceeded will be calculated for each week.
|
Weekly during the 1-month follow-up
|
|
Weekly overall proportion of time with temperature threshold violated
大体时间：Weekly during the 1-month follow-up
|
Overall proportion of monitoring time per week during which the temperature threshold is violated.
The temperature will be monitored at predefined measurement intervals during the 1-month follow-up.
For each measurement time point, the temperature will be compared with its respective predefined threshold.
The proportion of monitoring time points at which the temperature is violated will be calculated for each week.
|
Weekly during the 1-month follow-up
|
|
Weekly overall proportion of time with the relative humidity threshold violated
大体时间：Weekly during the 1-month follow-up
|
Overall proportion of monitoring time per week during which the relative humidity threshold is violated.
The relative humidity will be monitored at predefined measurement intervals during the 1-month follow-up.
For each measurement time point, the relative humidity will be compared with its respective predefined threshold.
The proportion of monitoring time points at which the relative humidity is violated will be calculated for each week.
|
Weekly during the 1-month follow-up
|
|
Weekly overall proportion of time with ambient light (day) threshold violated
大体时间：Weekly during the 1-month follow-up
|
Overall proportion of monitoring time per week during which the ambient light threshold is violated during the day-time hours.
The ambient light will be monitored at predefined measurement intervals during the 1-month follow-up.
For each measurement time point, ambient light will be compared with its respective predefined threshold.
The proportion of monitoring time points at which ambient light is violated during the day-time hours will be calculated for each week.
|
Weekly during the 1-month follow-up
|
|
Weekly overall proportion of time with ambient light (night) threshold violated
大体时间：Weekly during the 1-month follow-up
|
Overall proportion of monitoring time per week during which the ambient light threshold is violated during the night-time hours.
The ambient light will be monitored at predefined measurement intervals during the 1-month follow-up.
For each measurement time point, ambient light will be compared with its respective predefined threshold.
The proportion of monitoring time points at which ambient light is violated during the night-time hours will be calculated for each week.
|
Weekly during the 1-month follow-up
|
|
Weekly overall proportion of time with the ambient noise (night) threshold exceeded
大体时间：Weekly during the 1-month follow-up
|
Overall proportion of monitoring time per week during which the ambient noise threshold is exceeded during night-time hours.
The ambient noise will be monitored at predefined measurement intervals during the 1-month follow-up.
For each measurement time point, the ambient noise will be compared with its respective predefined threshold.
The proportion of monitoring time points at which ambient noise is exceeded during night-time hours will be calculated for each week.
|
Weekly during the 1-month follow-up
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：David Ruttens, MD, PhD、Ziekenhuis Oost-Limburg
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- O'Connor L, Wang B, Ye Z, Behar S, Tarrant S, Stamegna P, Pretz C, Dunkel L, Savage B, Scornavacca T, Shirshac J, Wilkie T, Toomey S, Mullen M, Fisher K, Tigas E, Wong S, McManus DD, Alper E, Martinez F, Walkey A, Lindenauer PK, Dickson E, Broach JP, Kheterpal V, Soni A. Evaluation of an integrated digital and mobile intervention to improve outcomes for patients with moderate to severe COPD. NPJ Digit Med. 2025 Jul 17;8(1):451. doi: 10.1038/s41746-025-01871-0.
- Shah AJ, Althobiani MA, Saigal A, Ogbonnaya CE, Hurst JR, Mandal S. Wearable technology interventions in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis. NPJ Digit Med. 2023 Nov 27;6(1):222. doi: 10.1038/s41746-023-00962-0.
- Hansel NN, McCormack MC, Belli AJ, Matsui EC, Peng RD, Aloe C, Paulin L, Williams DL, Diette GB, Breysse PN. In-home air pollution is linked to respiratory morbidity in former smokers with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2013 May 15;187(10):1085-90. doi: 10.1164/rccm.201211-1987OC.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月1日
初级完成 (估计的)
2027年10月1日
研究完成 (估计的)
2027年10月1日
研究注册日期
首次提交
2026年8月17日
首先提交符合 QC 标准的
2026年8月27日
首次发布 (实际的)
2026年9月2日
研究记录更新
最后更新发布 (实际的)
2026年9月2日
上次提交的符合 QC 标准的更新
2026年8月27日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- Z-2026041
- IMR6-00019 (其他赠款/资助编号：Interreg Meuse-Rhine)
- UH-2026049 (其他标识符：CME Hasselt University)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.