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
CompletedNAResults postedLast updated 15 January 2026
What this trial tests
NA trial testing Vivalink wearable device in Pulmonary Disease, Chronic Obstructive in 77 participants. Completed in 31 October 2023.
Adults 40 to 80, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Physical ActivityPrimary· Day 0(Baseline) and Day 8 to Day 14
An activity flag is extracted from the accelerometer by Vivalink, by using a predefined threshold for adult movement. For stair climbing, first periodic movement was determined, by using frequency analysis on specific time windows, and generating a ratio to the total spectrum indicating periodic activity over a certain threshold.
Day 0
Group
Value
95% CI
COPD Cohort
41.98
± 22.89
Day 8 to Day 14
Group
Value
95% CI
COPD Cohort
58.93
± 33.026
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart RatePrimary· Day 0(Baseline) and Day 8 to Day 14
Heart rate is provided by Vivalink.
Day 0
Group
Value
95% CI
COPD Cohort
86.4
± 7.953
Day 8 to Day 14
Group
Value
95% CI
COPD Cohort
81.26
± 9.237
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (SDRR, SDNN, SDNNI, RMSSD, ln(RMSSD))Primary· Day 0(Baseline) and Day 8 to Day 14
Heart rate variability reflecting differences in time intervals between 2 R-waves in the ECG (milliseconds) SDRR (Standard Deviation of Intervals between Heartbeats), SDNN (Standard Deviation of Intervals between Heartbeats, after removing abnormal Beats), SDNNI (Mean of the Standard Deviations of all the NN intervals for each 5 min Segment of a 24-h HRV Recording), and RMSSD (Mean of the Standard Deviations of all the NN intervals for each 5 min Segment of a 24-hour HRV Recording) and In(RMSDD)
SDRR: Day 0
Group
Value
95% CI
COPD Cohort
26.83
± 11.37
SDRR: Day 8-14
Group
Value
95% CI
COPD Cohort
23.34
± 10.867
SDNN: Day 0
Group
Value
95% CI
COPD Cohort
58.71
± 47.79
SDNN: Day 8-14
Group
Value
95% CI
COPD Cohort
52.82
± 39.419
SDNNI: Day 0
Group
Value
95% CI
COPD Cohort
69.51
± 63.18
SDNNI: Day 8-14
Group
Value
95% CI
COPD Cohort
63.18
± 33.537
RMSSD: Day 0
Group
Value
95% CI
COPD Cohort
55.37
± 59.658
RMSSD: Day 8-14
Group
Value
95% CI
COPD Cohort
53.73
± 73.024
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (pNN50)Primary· Day 0(Baseline) and Day 8 to Day 14
pNN50 is the percentage of adjacent NN intervals that differ from each other by more than 50 milliseconds.
Day 0
Group
Value
95% CI
COPD Cohort
0.12
± 0.198
Day 8-14
Group
Value
95% CI
COPD Cohort
0.11
± 0.197
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (Stress Index)Primary· Day 0(Baseline) and Day 8 to Day 14
Baevsky's Stress Index is a heart rate variability (HRV) measure used to assess autonomic nervous system activity and physiological stress, especially in monitoring chronic obstructive pulmonary disease (COPD) exacerbations. It is calculated as: amplitude of the mode (AMo) divided by two times the mode (Mo) multiplied by the difference between the maximum and minimum RR intervals (MxDMn). AMo is the percentage of RR intervals at the most frequent value, Mo is the most common RR interval, and MxDMn is the range of RR intervals. The index typically ranges from 50 to over 900. Lower values (50-15
Day 0
Group
Value
95% CI
COPD Cohort
108.43
± 94.236
Day 8-14
Group
Value
95% CI
COPD Cohort
99.86
± 81.076
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (LF and HF)Primary· Day 0(Baseline) and Day 8 to Day 14
Applying a Fast Fourier Transformation (FFT) or autoregressive (AR) modeling one can separate Heart rate variability (HRV) into its component ultra-low-frequency (ULF), very low frequency (VLF), Low-Frequency power (LF), and High-Frequency power (HF) rhythms that operate within different frequency ranges. Given in absolute values of power (milliseconds squared). LF power, low frequency power (0.04-0.15 Hz). HF power, high frequency power (0.15-0.40 Hz). LF/HF Ratio, spectral HRV index computed as (LF/HF).
LF: Day 0
Group
Value
95% CI
COPD Cohort
320.32
± 456.411
LF: Day 8-14
Group
Value
95% CI
COPD Cohort
287.19
± 399.897
HF: Day 0
Group
Value
95% CI
COPD Cohort
646.3
± 1234.891
HF: Day 8-14
Group
Value
95% CI
COPD Cohort
612.6
± 1542.947
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (LF/HF)Primary· Day 0(Baseline) and Day 8 to Day 14
Applying a Fast Fourier Transformation (FFT) or autoregressive (AR) modeling one can separate Heart rate variability (HRV) into its component ultra-low-frequency (ULF), very low frequency (VLF), Low-Frequency power (LF), and High-Frequency power (HF) rhythms that operate within different frequency ranges. Given in absolute values of power (milliseconds squared). LF power, low frequency power (0.04-0.15 Hz). HF power, high frequency power (0.15-0.40 Hz). LF/HF Ratio, spectral HRV index computed as (LF/HF).
LF/HF: Day 0
Group
Value
95% CI
COPD Cohort
1.38
± 1.211
LF/HF: Day 8-14
Group
Value
95% CI
COPD Cohort
1.51
± 1.204
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - TemperaturePrimary· Day 0(Baseline) and Day 8 to Day 14
Temperature is provided by Vivalink. The value for temperature is derived by Vivalink from the display temperature and then calibrated using initial calibration values, in an IP protected process. The sensor temperature is considered only as a relative value to evaluate changes in the temperature, and not as an objective human body temperature value, meaning no thresholds relative to normal human body temperature are considered, and it will not be used as a marker for fever or hypothermia.
Day 0
Group
Value
95% CI
COPD Cohort
36.77
± 1.155
Day 8 to 14
Group
Value
95% CI
COPD Cohort
37.14
± 1.239
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Respiratory RatePrimary· Day 0(Baseline) and Day 8 to Day 14
Respiration rate is provided by Vivalink.
Day 0
Group
Value
95% CI
COPD Cohort
21.42
± 1.903
Day 8 to Day 14
Group
Value
95% CI
COPD Cohort
20.92
± 2.247
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Cough FrequencyPrimary· Day 0(Baseline) and Day 8 to Day 14
Cough Frequency was provided by vivalink.
Day 0
Group
Value
95% CI
COPD Cohort
56.82
± 48.46
Day 8 to Day 14
Group
Value
95% CI
COPD Cohort
72.46
± 58.62
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Sleep PatternsPrimary· Day 0(Baseline) and Day 8 to Day 14
The basis of the sleep pattern calculations is the self-reported bedtimes. With the same technique as the cough frequency prediction, inactivity signals can be predicted from the labeled data to improve the bedtime accuracy, and the changes in accelerometer (step detection algorithms) can be used to quantify the number of clear breaks in the sleep (standing up, strong cough, etc.).
Day 0
Group
Value
95% CI
COPD Cohort
8.7
± 1.892
Day 8 to Day 14
Group
Value
95% CI
COPD Cohort
8.48
± 1.491
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Resting Heart RatePrimary· Day 0(Baseline) and Day 8 to Day 14
Resting Heart Rate is provided by Vivalink.
Day 0
Group
Value
95% CI
COPD Cohort
85.02
± 8.003
Day 8 to Day 14
Group
Value
95% CI
COPD Cohort
79.9
± 9.126
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 3 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Last refreshed: 15 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05655832.