COPD (Chronic Obstructive Pulmonary Disease)COPD-AIRNCT07799896
The Impact of Indoor Environmental Quality on Symptoms in Patients With Chronic Obstructive Pulmonary Disease
A study testing Wearable mobile device, Indoor environmental quality sensor and CAT Questionnaire in people with COPD (Chronic Obstructive Pulmonary Disease) and Acute Exacerbation of COPD, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Acute Exacerbation of COPD
- What is being tested?
- Wearable mobile device, Indoor environmental quality sensor and CAT Questionnaire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2026to Oct 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Femke Wouters, PhD contact
Belgium1 site
Ziekenhuis Oost-Limburg
Genk, 3600
Ruben Knevels, MsC, +3289804029, ruben.knevels@zol.be
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Wearable mobile device, Indoor environmental quality sensor, CAT Questionnaire, PSQI Questionnaire, KSS Questionnaire
- Keywords
- Mobile health, COPD, Remote monitoring, AECOPD, Air quality, Environmental quality, Indoor air quality
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable mobile deviceDevice
Also called Garmin Venu
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.
Indoor environmental quality sensorDevice
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.
CAT QuestionnaireOther
A COPD Assessment Test questionnaire will be taken during the hospitalization (start of the study), and weekly after discharge.
PSQI QuestionnaireOther
A Pittsburgh Sleep Quality Index questionnaire will be taken 4 weeks after hospital discharge (end of the study).
KSS QuestionnaireOther
A Karolinska Sleepiness Scale questionnaire will be taken daily after discharge.
SQS QuestionnaireOther
A sleep quality scale questionnaire will be taken daily after discharge.
PROMs QuestionnaireOther
A PROMs questionnaire will be taken daily after discharge.
eHLQ QuestionnaireOther
An eHealth literacy questionnaire will be taken during the hospitalization (start of the study), and 4 weeks after hospital discharge (end of the study).
Housing QuestionnaireOther
A housing questionnaire will be taken during the hospitalization (start of the study).
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted with an acute COPD exacerbation | Experimental | Wearable mobile device (Garmin Venu) \& Indoor environmental quality sensor Receives: Device: Wearable mobile device; Device: Indoor environmental quality sensor; Other: CAT Questionnaire; Other: PSQI Questionnaire; Other: KSS Questionnaire; Other: SQS Questionnaire; Other: PROMs Questionnaire; Other: eHLQ Questionnaire; Other: Housing Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly score of COPD symptom burden assessed using the COPD Assessment Test (CAT)
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.
Measured: Baseline and weekly during the 1-month follow-up
Weekly mean PM0.5 concentration
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.
Measured: Weekly during the 1-month follow-up
Weekly mean PM2.5 concentration
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.
Measured: Weekly during the 1-month follow-up
Weekly mean PM4 concentration
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.
Measured: Weekly during the 1-month follow-up
Weekly mean PM10 concentration
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.
Measured: Weekly during the 1-month follow-up
Weekly mean CO2 concentration
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.
Measured: Weekly during the 1-month follow-up
Weekly mean VOC concentration
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.
Measured: Weekly during the 1-month follow-up
Weekly mean temperature
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.
Measured: Weekly during the 1-month follow-up
Weekly mean relative humidity
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.
Measured: Weekly during the 1-month follow-up
Weekly mean ambient light - day
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.
Measured: Weekly during the 1-month follow-up
Weekly mean ambient light - night
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.
Measured: Weekly during the 1-month follow-up
Weekly mean ambient noise - night
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.
Measured: Weekly during the 1-month follow-up
Weekly overall proportion of time with at least one IEQ threshold violated
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.
Measured: Weekly during the 1-month follow-up
Secondary outcomes (34)
Feasibility - Measurement completeness
Proportion of expected IEQ measurements successfully recorded.
Measured: During follow-up (1 month)
Feasibility - Valid monitoring time
Duration of valid monitoring time per participant.
Measured: During follow-up (1 month)
Daily perceived change in health status
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.
Measured: Daily during follow-up (1 month)
Feasibility - Frequency of data gaps
Frequency of gaps in monitoring data.
Measured: During follow-up (1 month)
Feasibility - Duration of data gaps
Duration of gaps in monitoring data.
Measured: During follow-up (1 month)
Wearable-derived health insights - Heart rate
Heart rate (BPM) measured using the wearable.
Measured: Continuous monitoring during follow-up (1 month)
Wearable-derived health insights - Respiratory rate
Respiratory rate (BPM) measured using the wearable.
Measured: Continuous monitoring during follow-up (1 month)
Wearable-derived health insights - Oxygen saturation
Oxygen saturation (%) measured using the wearable.
Measured: Continuous monitoring during follow-up (1 month)
Wearable-derived health insights - Skin temperature
Nightly deviation in skin temperature (°C) compared with the previous night, measured using the wearable.
Measured: Continuous monitoring during follow-up (1 month)
Sleep quality - PSQI
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.
Measured: End of study (one month)
Sleepiness - KSS
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.
Measured: Daily during the 1-month follow-up
Sleep quality - SQS
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.
Measured: Daily during the 1-month follow-up
Wearable-derived sleep metrics - Sleep duration
Nightly sleep duration (hours) measured using the wearable.
Measured: Nightly during the 1-month follow-up
Wearable-derived sleep metrics - Sleep score
Nightly sleep score measured using the wearable. Score from 0-100, with a higher score indicating better quality of sleep.
Measured: Nightly during the 1-month follow-up
Wearable-derived sleep metrics - Time in sleep cycle
Nightly time spent in REM, deep, and light sleep (hours).
Measured: Nightly during the 1-month follow-up
Wearable-derived physical activity - Daily step count
Daily step count (number) measured by the wearable.
Measured: Daily during the 1-month follow-up
Wearable-derived physical activity - Activity minutes
Daily activity minutes (minutes) measured by the wearable.
Measured: Daily during the 1-month follow-up
Concentration of outside air quality
Concentration of outside air quality measure (PM, expressed in µg/m³) based on the participant's residential area.
Measured: During follow-up (1 month)
COPD exacerbations
Occurrence of a COPD exacerbation during the follow-up period.
Measured: During follow-up (1 month)
eHealth literacy
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.
Measured: Baseline and end of study (one month)
Change in eHealth literacy
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.
Measured: Baseline and end of study (one month)
Housing characteristics
Sociodemographic characteristics, housing characteristics, and indoor environmental factors assessed using the Housing Conditions Questionnaire.
Measured: Baseline
Weekly overall proportion of time with PM0.5 threshold exceeded
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.
Measured: Weekly during the 1-month follow-up
Weekly overall proportion of time with PM1 threshold exceeded
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.
Measured: Weekly during the 1-month follow-up
Weekly overall proportion of time with PM2.5 threshold exceeded
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.
Measured: Weekly during the 1-month follow-up
Weekly overall proportion of time with PM4 threshold exceeded
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.
Measured: Weekly during the 1-month follow-up
Weekly overall proportion of time with PM10 threshold exceeded
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.
Measured: Weekly during the 1-month follow-up
Weekly overall proportion of time with CO2 threshold exceeded
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.
Measured: Weekly during the 1-month follow-up
Weekly overall proportion of time with VOC threshold exceeded
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.
Measured: Weekly during the 1-month follow-up
Weekly overall proportion of time with temperature threshold violated
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.
Measured: Weekly during the 1-month follow-up
Weekly overall proportion of time with the relative humidity threshold violated
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.
Measured: Weekly during the 1-month follow-up
Weekly overall proportion of time with ambient light (day) threshold violated
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.
Measured: Weekly during the 1-month follow-up
Weekly overall proportion of time with ambient light (night) threshold violated
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.
Measured: Weekly during the 1-month follow-up
Weekly overall proportion of time with the ambient noise (night) threshold exceeded
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.
Measured: Weekly during the 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University, University of Liege, Hasselt University, KU Leuven
- Responsible party
- Sponsor
- Investigators
- David Ruttens, MD, PhD, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799896
- Sponsor's protocol ID
- Z-2026041
- Other IDs
- IMR6-00019, UH-2026049
- Acronym
- COPD-AIR
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 40676130Shah 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.
PubMed 38012218Hansel 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.
PubMed 23525930