N/A
Completed N=77
A Study to Investigate the Association of Real-world Sensor-derived Biometric Data With Clinical Parameters and Patient-reported Outcomes for Monitoring Disease Activity in Patients With COPD
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT05655832 ↗
Enrolled (actual)
77
Serious AEs
2.2%
Results posted
Jan 2026
Primary outcomePrimary: Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Physical Activity — 41.98; 58.93 minutes
Summary
The purpose of this multicenter, prospective cohort study is to investigate the correlation of real-world sensor-derived biometric data obtained via a wearable device with clinical parameters and patient-reported outcomes (PROs) for monitoring disease activity and predicting exacerbations for participants with Chronic Obstructive Pulmonary Disease (COPD). The cohort of participants with COPD will be followed for 3 months. A calibration cohort with non-COPD participants will be included and followed for 2 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Physical Activity |
41.98; 58.93 | — |
| PRIMARY Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate |
86.4; 81.26 | — |
| PRIMARY Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (SDRR, SDNN, SDNNI, RMSSD, ln(RMSSD)) |
26.83; 23.34; 58.71; 52.82; 69.51; 63.18 | — |
| PRIMARY Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (pNN50) |
0.12; 0.11 | — |
| PRIMARY Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (Stress Index) |
108.43; 99.86 | — |
| PRIMARY Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (LF and HF) |
320.32; 287.19; 646.3; 612.6 | — |
| PRIMARY Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (LF/HF) |
1.38; 1.51 | — |
| PRIMARY Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Temperature |
36.77; 37.14 | — |
| PRIMARY Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Respiratory Rate |
21.42; 20.92 | — |
| PRIMARY Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Cough Frequency |
56.82; 72.46 | — |
| PRIMARY Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Sleep Patterns |
8.7; 8.48 | — |
| PRIMARY Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Resting Heart Rate |
85.02; 79.9 | — |
| PRIMARY Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Inspiration vs Expiration Time Ratio |
0.96; 0.98 | — |
| PRIMARY Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Frequency of Additional Medication |
0.37; 0.82 | — |
| PRIMARY Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Accuracy |
0.56; 0.56 | — |
| PRIMARY Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Precision |
0.53; 0.62 | — |
| PRIMARY Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Recall |
0.63; 0.46 | — |
| PRIMARY Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Specificity |
0.53; 0.63 | — |
| SECONDARY Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End |
0.19; 0.45; 0.19; 0.46; 0.07; 0.02 | — |
| SECONDARY Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End |
0.07; -0.36; 0.08; -0.32; -0.29; -0.12 | — |
| SECONDARY Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End |
0.11; -0.15; 0.13; -0.11; -0.21; -0.28 | — |
| SECONDARY Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End |
-0.07; -0.3; -0.08; -0.29; -0.16; 0.15 | — |
| SECONDARY Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) |
0.2; -0.07; 0.21; -0.04; 0.19; 0.34 | — |
| SECONDARY Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) |
0.01; 0.11; 0.02; 0.1; 0.48; 0.21 | — |
| SECONDARY Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) |
-0.39; -0.3; -0.41; -0.3; -0.3; -0.24 | — |
| SECONDARY Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) |
0.16; 0.32; 0.18; 0.3; 0.13; -0.26 | — |
| SECONDARY Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) |
-0.33; -0.32; -0.35; -0.33; -0.29; 0.03 | — |
| SECONDARY Correlation of Sensor-Collected Data With Number, Date of Onset, and Duration of Mild, Moderate, and Severe Exacerbations |
NA | — |
| SECONDARY Association Between Sensor Parameters (Heart Rate and Resting Heart Rate) and CAT Score |
0.039; 0.039 | — |
| SECONDARY Association Between Sensor Parameters (Respiration Rate) and CAT Score |
0.370; 0.789 | — |
| SECONDARY Association Between Sensor Parameters (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)) and CAT Score |
0.030; 0.010; 0.029; 0.011; 0.045; 0.006 | — |
| SECONDARY Association Between Sensor Parameters (Stress Index, LF/HF) and CAT Score |
0.003; -0.006; -0.441; -0.963 | — |
| SECONDARY Association Between Sensor Parameters (pNN50) and CAT Score |
2.259; 5.483 | — |
| SECONDARY Association Between Sensor Parameters (Temperature) and CAT Score |
0.943 | — |
| SECONDARY Association Between Sensor Parameters (Physical Activity) and CAT Score |
-0.016 | — |
| SECONDARY Association Between Sensor Parameters (Sleep Pattern) and CAT Score |
-0.292 | — |
| SECONDARY Predicting the CAT Score by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates |
82.7; 82.6 | — |
Eligibility Criteria
Inclusion Criteria
For participants with COPD:
- Participants ≥40 and ≤80 years at baseline
- Diagnosis of COPD stage II to IV
- History of moderate or severe exacerbations (≥2 moderate exacerbations or ≥1 severe exacerbations in any 12-month time window during last 3 years prior to inclusion and ≥1 moderate or severe exacerbations in the last 12 months prior to inclusion, considering that the last 12 months may reflect lower exacerbation rate due to Covid-19 measures)
For participants in the calibration cohort:
- Participants ≥40 and ≤80 years at baseline
Exclusion Criteria
For participants with COPD:
- Clinically relevant and/or serious concurrent medical conditions including, but not limited to visual problems, severe mental illness or cognitive impairment, musculoskeletal or movement disorders, cardiac disease (e.g., heart failure, arrythmia [esp. atrial fibrillation and conduction blocks]), lung cancer (currently treated) that in the opinion of the Investigator, would interfere with participant's ability to participate in the study or draw meaningful conclusions from the study
- Participants with a cardiac pacemaker, defibrillators, or other implanted electronic devices
- Participants with known allergies or sensitivity to silicon or hydrogel
- Less than 6 weeks since previous moderate/severe exacerbation
For participants in the calibration cohort:
- Participants with a cardiac pacemaker, defibrillators, or other implanted electronic devices
- Participants with known allergies or sensitivity to silicon or hydrogel
- Diagnosis of pulmonary disease including, but not limited to COPD, asthma, pulmonary fibrosis, with impact on the lung function and exercise capacity
Data sourced from ClinicalTrials.gov (NCT05655832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.