The Impact of Indoor Environmental Quality on Symptoms in Patients With Chronic Obstructive Pulmonary Disease

NCT07799896 | Not Yet Recruiting

• 3 other identifiers: Z-2026041IMR6-00019UH-2026049
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Acute Exacerbation of COPD

Keywords

Mobile health; COPD; Remote monitoring; AECOPD; Air quality; Environmental quality; Indoor air quality

Outcome Measures

Primary Outcomes (13)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Weekly during the 1-month follow-up

Secondary Outcomes (34)

• Feasibility - Measurement completeness

  During follow-up (1 month)

• Feasibility - Valid monitoring time

  During follow-up (1 month)

• Daily perceived change in health status

  Daily during follow-up (1 month)

• Feasibility - Frequency of data gaps

  During follow-up (1 month)

• Feasibility - Duration of data gaps

  During follow-up (1 month)

Study Arms (1)

Patients admitted with an acute COPD exacerbation

EXPERIMENTAL

Wearable mobile device (Garmin Venu) \& Indoor environmental quality sensor

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

Interventions

Indoor environmental quality sensor DEVICE

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.

Patients admitted with an acute COPD exacerbation

KSS Questionnaire OTHER

A Karolinska Sleepiness Scale questionnaire will be taken daily after discharge.

Patients admitted with an acute COPD exacerbation

SQS Questionnaire OTHER

A sleep quality scale questionnaire will be taken daily after discharge.

Patients admitted with an acute COPD exacerbation

PROMs Questionnaire OTHER

A PROMs questionnaire will be taken daily after discharge.

Patients admitted with an acute COPD exacerbation

eHLQ Questionnaire OTHER

An eHealth literacy questionnaire will be taken during the hospitalization (start of the study), and 4 weeks after hospital discharge (end of the study).

Patients admitted with an acute COPD exacerbation

Housing Questionnaire OTHER

A housing questionnaire will be taken during the hospitalization (start of the study).

Patients admitted with an acute COPD exacerbation

CAT Questionnaire OTHER

A COPD Assessment Test questionnaire will be taken during the hospitalization (start of the study), and weekly after discharge.

Patients admitted with an acute COPD exacerbation

PSQI Questionnaire OTHER

A Pittsburgh Sleep Quality Index questionnaire will be taken 4 weeks after hospital discharge (end of the study).

Patients admitted with an acute COPD exacerbation

Wearable mobile device 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.

Also known as: Garmin Venu

Patients admitted with an acute COPD exacerbation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead
• Maastricht University: collaborator
• University of Liege: collaborator
• Hasselt University: collaborator
• KU Leuven: collaborator

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

Related Publications (3)

• 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.

  PMID: 40676130 BACKGROUND

• 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.

  PMID: 38012218 BACKGROUND

• 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.

  PMID: 23525930 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Ruttens, MD, PhD

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruben Knevels, MsC

CONTACT

+3289804029; ruben.knevels@zol.be

Femke Wouters, PhD

CONTACT

femke.wouters@zol.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: September 2, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)