Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

The Impact of Indoor Environmental Quality on Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD-AIR)

27. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

15

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Belgien
      • Genk, Belgien, 3600
        • Ziekenhuis Oost-Limburg
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Patients admitted with an acute COPD exacerbation
Wearable mobile device (Garmin Venu) & Indoor environmental quality sensor
Gerät: Wearable mobile device
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.
Andere Namen:
  • Garmin Venu
Gerät: Indoor environmental quality sensor
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.
Sonstiges: CAT Questionnaire
A COPD Assessment Test questionnaire will be taken during the hospitalization (start of the study), and weekly after discharge.
Sonstiges: PSQI Questionnaire
A Pittsburgh Sleep Quality Index questionnaire will be taken 4 weeks after hospital discharge (end of the study).
Sonstiges: KSS Questionnaire
A Karolinska Sleepiness Scale questionnaire will be taken daily after discharge.
Sonstiges: SQS Questionnaire
A sleep quality scale questionnaire will be taken daily after discharge.
Sonstiges: PROMs Questionnaire
A PROMs questionnaire will be taken daily after discharge.
Sonstiges: eHLQ Questionnaire
An eHealth literacy questionnaire will be taken during the hospitalization (start of the study), and 4 weeks after hospital discharge (end of the study).
Sonstiges: Housing Questionnaire
A housing questionnaire will be taken during the hospitalization (start of the study).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Weekly score of COPD symptom burden assessed using the COPD Assessment Test (CAT)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Feasibility - Measurement completeness
Zeitfenster: During follow-up (1 month)
Proportion of expected IEQ measurements successfully recorded.
During follow-up (1 month)
Feasibility - Valid monitoring time
Zeitfenster: During follow-up (1 month)
Duration of valid monitoring time per participant.
During follow-up (1 month)
Daily perceived change in health status
Zeitfenster: 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
Zeitfenster: During follow-up (1 month)
Frequency of gaps in monitoring data.
During follow-up (1 month)
Feasibility - Duration of data gaps
Zeitfenster: During follow-up (1 month)
Duration of gaps in monitoring data.
During follow-up (1 month)
Wearable-derived health insights - Heart rate
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: During follow-up (1 month)
Occurrence of a COPD exacerbation during the follow-up period.
During follow-up (1 month)
eHealth literacy
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ziekenhuis Oost-Limburg

Mitarbeiter

KU Leuven
Hasselt University
University of Liege
Maastricht University

Ermittler

  • Hauptermittler: David Ruttens, MD, PhD, Ziekenhuis Oost-Limburg

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Oktober 2026

Primärer Abschluss (Geschätzt)

1. Oktober 2027

Studienabschluss (Geschätzt)

1. Oktober 2027

Studienanmeldedaten

Zuerst eingereicht

17. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. August 2026

Zuerst gepostet (Tatsächlich)

2. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • Z-2026041
  • IMR6-00019 (Andere Zuschuss-/Finanzierungsnummer: Interreg Meuse-Rhine)
  • UH-2026049 (Andere Kennung: CME Hasselt University)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren