18 and older, any sex, with Heart Failure. 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.
Accuracy of CPM System Calculated RR Versus Reference Device Via Percent of Error Accuracy of Respiration RatePrimary· up to 3 hours
Accuracy of CPM System calculated RR versus reference device reported as percentage of respiration rate error within +/- breath rates per minute. Acceptance for clinical utility is \>= 85%. Percentage of respiration rate error within ± 2bpm. Acceptance criteria for clinical utility is \>= 85%. The percentage of respiration rate within ± 2brpm was calculated by data points, regardless of its rate and breathing condition, which the CPM System did not screen, therefore reporting the numeric values. Each data point will produce binary result (True or False) if the error is within ± 2 brpm. Assumin
Group
Value
95% CI
Supine Position Measurements
96.3
94.5 – 97.6
Upright Position Measurements
95.7
93.8 – 97.2
Root Mean Squared Error (RMSE) of Respiration Rates From the CPM System vs Reference Device for Metronome Guided Breathing and Non-metronome Guided Breathing.Primary· up to 3 hours
Root mean square (RMS) of residual relative error of relative tidal volume. Acceptance criteria for clinical utility is \<= 35%. First, the subject-specific linear fitting is performed after taking the natural log of both CPM's rTV and reference TV. Then, the residual errors in rTV after the fitting were calculated. Finally, all subject's residual errors are pooled together to calculate the root mean squared (RMS) residual relative errors. The confidence interval was calculated assuming the square of this error follows Chi-square distribution. This error characterized in a log-log domain is co
Group
Value
95% CI
Supine Position Measurements
23.6
22.2 – 25.3
Upright Position Measurements
32.6
30.4 – 35.0
Accuracy of CPM System Calculated Respiration Rate Versus Reference Device, Reported as Root Mean Squared (RMS) ErrorSecondary· up to 3 hours
Accuracy of CPM System calculated RR versus reference device. It is reported in Root Mean Squared error for both exercises with metronome guided breathing and non-metronome guided breathing. Acceptance criteria of substantial equivalence is \~1.6 breath rates per minute (BRPM) for metronome guided breathing and 3.0 BRPM for non-metronome guided breathing.
Root Mean Squared Error - Metronome Guided breathing
Group
Value
95% CI
Supine Position Measurements
1.09
Upright Position Measurements
1.29
Root Mean Squared Error - Non-Metronome Guided breathing
Group
Value
95% CI
Supine Position Measurements
0.91
Upright Position Measurements
1.91
CPM's ECG Metrics Compared to Reference Device Lead II ECG Metrics (Results Displayed as % Comparasion)Secondary· up to 3 hours
Test the CPM System ECG strip against a lead II ECG strip. Results are displayed as % of CPM strips equivalent to Lead II ECG strips. One CPM ECG strip and one reference lead II strip were analyzed per patient.
Quality QRS presentation
Group
Value
95% CI
Health Adult
100
QRS width measurability
Group
Value
95% CI
Health Adult
100
Accurate Determination of QRS widening
Group
Value
95% CI
Health Adult
94.9
QT interval measurability
Group
Value
95% CI
Health Adult
100
A-Fib Rhythm readability
Group
Value
95% CI
Health Adult
100
Test Device Skin Temperature vs Reference Device Skin Temperature ComparisonSecondary· up to 3 hours
The accuracy is characterized as mean error across all measurement items and all subjects.
Group
Value
95% CI
Health Adult
0.02
± .81
Sponsor's own description
This study is designed to be a clinical validation study to ready the CPM System for FDA 510(k) submission. This study will be conducted as a prospective non-randomized. The study is non-significant risk since the CPM Device is noninterventional and noninvasive. The study is primarily designed to validate the accuracy of the respiration rate and the changes in relative tidal volume. All participants will be fitted with both the CPM Device as well as reference devices (capnography and ECG). Participants will be randomized between 4 procedures (A-D) which will determine the order of 18 exercises. Each exercise has about 2 minutes of device recording and two minutes of rest. Each exercise contains two positions: sitting up for one minute and lying down for one minute. For some exercises, the participant will be instructed to breathe at a certain rate (assisted by a metronome). For other exercises, the participants will breathe at a normal rate but change how deep the are breathing. For exercise 18, all capnography reference devices will be removed, and an ECG reference device will be placed. After exercise 18, the participant will have all devices removed and the study visit will terminate. The participant will receive a safety follow-up call about 1 week after their visit.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Analog Device, Inc.
Last refreshed: 12 June 2024
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/NCT05445206.