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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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

15

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

      • Genk、ベルギー、3600
        • Ziekenhuis Oost-Limburg
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Patients admitted with an acute COPD exacerbation
Wearable mobile device (Garmin Venu) & Indoor environmental quality sensor
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.
他の名前:
  • Garmin Venu
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).

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Weekly score of COPD symptom burden assessed using the COPD Assessment Test (CAT)
時間枠:Baseline and weekly during the 1-month follow-up
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.
Baseline and weekly during the 1-month follow-up
Weekly mean PM0.5 concentration
時間枠:Weekly during the 1-month follow-up
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.
Weekly during the 1-month follow-up
Weekly mean PM2.5 concentration
時間枠:Weekly during the 1-month follow-up
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.
Weekly during the 1-month follow-up
Weekly mean PM4 concentration
時間枠: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
Weekly mean PM10 concentration
時間枠: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.
Weekly during the 1-month follow-up
Weekly mean CO2 concentration
時間枠:Weekly during the 1-month follow-up
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.
Weekly during the 1-month follow-up
Weekly mean VOC concentration
時間枠:Weekly during the 1-month follow-up
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.
Weekly during the 1-month follow-up
Weekly mean temperature
時間枠:Weekly during the 1-month follow-up
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.
Weekly during the 1-month follow-up
Weekly mean relative humidity
時間枠: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.
Weekly during the 1-month follow-up
Weekly mean ambient light - day
時間枠: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.
Weekly during the 1-month follow-up
Weekly mean ambient light - night
時間枠: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 night-time hours will be aggregated to calculate a weekly mean ambient light - night.
Weekly during the 1-month follow-up
Weekly mean ambient noise - night
時間枠:Weekly during the 1-month follow-up
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.
Weekly during the 1-month follow-up
Weekly overall proportion of time with at least one IEQ threshold violated
時間枠:Weekly during the 1-month follow-up
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.
Weekly during the 1-month follow-up

二次結果の測定

結果測定
メジャーの説明
時間枠
Feasibility - Measurement completeness
時間枠:During follow-up (1 month)
Proportion of expected IEQ measurements successfully recorded.
During follow-up (1 month)
Feasibility - Valid monitoring time
時間枠:During follow-up (1 month)
Duration of valid monitoring time per participant.
During follow-up (1 month)
Daily perceived change in health status
時間枠:Daily during follow-up (1 month)
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.
Daily during follow-up (1 month)
Feasibility - Frequency of data gaps
時間枠:During follow-up (1 month)
Frequency of gaps in monitoring data.
During follow-up (1 month)
Feasibility - Duration of data gaps
時間枠:During follow-up (1 month)
Duration of gaps in monitoring data.
During follow-up (1 month)
Wearable-derived health insights - Heart rate
時間枠:Continuous monitoring during follow-up (1 month)
Heart rate (BPM) measured using the wearable.
Continuous monitoring during follow-up (1 month)
Wearable-derived health insights - Respiratory rate
時間枠:Continuous monitoring during follow-up (1 month)
Respiratory rate (BPM) measured using the wearable.
Continuous monitoring during follow-up (1 month)
Wearable-derived health insights - Oxygen saturation
時間枠:Continuous monitoring during follow-up (1 month)
Oxygen saturation (%) measured using the wearable.
Continuous monitoring during follow-up (1 month)
Wearable-derived health insights - Skin temperature
時間枠:Continuous monitoring during follow-up (1 month)
Nightly deviation in skin temperature (°C) compared with the previous night, measured using the wearable.
Continuous monitoring during follow-up (1 month)
Sleep quality - PSQI
時間枠: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.
End of study (one month)
Sleepiness - KSS
時間枠:Daily during the 1-month follow-up
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
時間枠: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.
Daily during the 1-month follow-up
Wearable-derived sleep metrics - Sleep duration
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:During follow-up (1 month)
Occurrence of a COPD exacerbation during the follow-up period.
During follow-up (1 month)
eHealth literacy
時間枠: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.
Baseline and end of study (one month)
Change in eHealth literacy
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:David Ruttens, MD, PhD、Ziekenhuis Oost-Limburg

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年10月1日

一次修了 (推定)

2027年10月1日

研究の完了 (推定)

2027年10月1日

試験登録日

最初に提出

2026年8月17日

QC基準を満たした最初の提出物

2026年8月27日

最初の投稿 (実際)

2026年9月2日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月2日

QC基準を満たした最後の更新が送信されました

2026年8月27日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • Z-2026041
  • IMR6-00019 (その他の助成金/資金番号:Interreg Meuse-Rhine)
  • UH-2026049 (その他の識別子:CME Hasselt University)

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はい

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