The Impact of Indoor Environmental Quality on Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD-AIR)
2026년 8월 27일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
중재적
등록 (추정된)
15
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Ruben Knevels, MsC
- 전화번호: +3289804029
- 이메일: ruben.knevels@zol.be
연구 연락처 백업
- 이름: Femke Wouters, PhD
- 이메일: femke.wouters@zol.be
연구 장소
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Genk, 벨기에, 3600
- Ziekenhuis Oost-Limburg
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연락하다:
- Ruben Knevels, MsC
- 전화번호: +3289804029
- 이메일: ruben.knevels@zol.be
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
다른 이름들:
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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Weekly score of COPD symptom burden assessed using the COPD Assessment Test (CAT)
기간: 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
기간: 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
기간: 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
기간: Weekly during the 1-month follow-up
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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.
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Weekly during the 1-month follow-up
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Weekly mean PM10 concentration
기간: Weekly during the 1-month follow-up
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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
기간: 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
기간: 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
기간: 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
기간: Weekly during the 1-month follow-up
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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
기간: 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 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Feasibility - Measurement completeness
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Continuous monitoring during follow-up (1 month)
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Heart rate (BPM) measured using the wearable.
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Continuous monitoring during follow-up (1 month)
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Wearable-derived health insights - Respiratory rate
기간: Continuous monitoring during follow-up (1 month)
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Respiratory rate (BPM) measured using the wearable.
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Continuous monitoring during follow-up (1 month)
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Wearable-derived health insights - Oxygen saturation
기간: Continuous monitoring during follow-up (1 month)
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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
기간: 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.
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Continuous monitoring during follow-up (1 month)
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Sleep quality - PSQI
기간: End of study (one month)
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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
기간: 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.
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Daily during the 1-month follow-up
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Sleep quality - SQS
기간: Daily during the 1-month follow-up
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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
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Wearable-derived sleep metrics - Sleep duration
기간: Nightly during the 1-month follow-up
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Nightly sleep duration (hours) measured using the wearable.
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Nightly during the 1-month follow-up
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Wearable-derived sleep metrics - Sleep score
기간: Nightly during the 1-month follow-up
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Nightly sleep score measured using the wearable.
Score from 0-100, with a higher score indicating better quality of sleep.
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Nightly during the 1-month follow-up
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Wearable-derived sleep metrics - Time in sleep cycle
기간: Nightly during the 1-month follow-up
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Nightly time spent in REM, deep, and light sleep (hours).
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Nightly during the 1-month follow-up
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Wearable-derived physical activity - Daily step count
기간: Daily during the 1-month follow-up
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Daily step count (number) measured by the wearable.
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Daily during the 1-month follow-up
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Wearable-derived physical activity - Activity minutes
기간: Daily during the 1-month follow-up
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Daily activity minutes (minutes) measured by the wearable.
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Daily during the 1-month follow-up
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Concentration of outside air quality
기간: During follow-up (1 month)
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Concentration of outside air quality measure (PM, expressed in µg/m³) based on the participant's residential area.
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During follow-up (1 month)
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COPD exacerbations
기간: During follow-up (1 month)
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Occurrence of a COPD exacerbation during the follow-up period.
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During follow-up (1 month)
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eHealth literacy
기간: Baseline and end of study (one month)
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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)
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Change in eHealth literacy
기간: Baseline and end of study (one month)
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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.
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Baseline and end of study (one month)
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Housing characteristics
기간: Baseline
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Sociodemographic characteristics, housing characteristics, and indoor environmental factors assessed using the Housing Conditions Questionnaire.
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Baseline
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Weekly overall proportion of time with PM0.5 threshold exceeded
기간: Weekly during the 1-month follow-up
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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.
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Weekly during the 1-month follow-up
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Weekly overall proportion of time with PM1 threshold exceeded
기간: Weekly during the 1-month follow-up
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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.
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Weekly during the 1-month follow-up
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Weekly overall proportion of time with PM2.5 threshold exceeded
기간: Weekly during the 1-month follow-up
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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.
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Weekly during the 1-month follow-up
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Weekly overall proportion of time with PM4 threshold exceeded
기간: Weekly during the 1-month follow-up
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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.
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Weekly during the 1-month follow-up
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Weekly overall proportion of time with PM10 threshold exceeded
기간: Weekly during the 1-month follow-up
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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.
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Weekly during the 1-month follow-up
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Weekly overall proportion of time with CO2 threshold exceeded
기간: Weekly during the 1-month follow-up
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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.
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Weekly during the 1-month follow-up
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Weekly overall proportion of time with VOC threshold exceeded
기간: Weekly during the 1-month follow-up
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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.
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Weekly during the 1-month follow-up
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Weekly overall proportion of time with temperature threshold violated
기간: Weekly during the 1-month follow-up
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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.
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Weekly during the 1-month follow-up
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Weekly overall proportion of time with the relative humidity threshold violated
기간: Weekly during the 1-month follow-up
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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.
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Weekly during the 1-month follow-up
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Weekly overall proportion of time with ambient light (day) threshold violated
기간: Weekly during the 1-month follow-up
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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.
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Weekly during the 1-month follow-up
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Weekly overall proportion of time with ambient light (night) threshold violated
기간: Weekly during the 1-month follow-up
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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.
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Weekly during the 1-month follow-up
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Weekly overall proportion of time with the ambient noise (night) threshold exceeded
기간: Weekly during the 1-month follow-up
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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.
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Weekly during the 1-month follow-up
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: David Ruttens, MD, PhD, Ziekenhuis Oost-Limburg
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 10월 1일
기본 완료 (추정된)
2027년 10월 1일
연구 완료 (추정된)
2027년 10월 1일
연구 등록 날짜
최초 제출
2026년 8월 17일
QC 기준을 충족하는 최초 제출
2026년 8월 27일
처음 게시됨 (실제)
2026년 9월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 27일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Z-2026041
- IMR6-00019 (기타 보조금/기금 번호: Interreg Meuse-Rhine)
- UH-2026049 (기타 식별자: CME Hasselt University)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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