Cardiopulmonary Disease
Conditions
Brief summary
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 10 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 the last, 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.
Interventions
DEVICECPM Device
The CPM device and reference device are used simultaneous to validate the CPM device.
Sponsors
Clayton Sleep Insititute
Analog Device, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Non-randomized control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults over the age of 18 and who are willing and able to give informed consent * Willing and able to participate in all activities related to this study, including trimming chest hair and wearing a reference device and the CPM wearable device * Volunteers of any race, any gender * Range of physiques * Healthy
Exclusion criteria
* Injury or skin disturbance in the area of the test device * Allergies or sensitivities to silicone/acrylic-based adhesive * Pregnant * Currently smokes cigarettes * Has known respiratory conditions that might prevent them from following the study procedure such as: * Flu * Pneumonia/bronchitis * Shortness of breath/respiratory distress * Respiratory or lung surgery * Emphysema, COPD, lung disease * Has self-reported heart or cardiovascular conditions such as chest pain, AFib, CHF, cardiomyopathy, or other conditions that could interfere with cardiopulmonary function * Has other self-reported health conditions that could interfere with the breathing patterns and exercises detailed in the protocol (including wearing a capnography mask)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of CPM System Calculated RR Versus Reference Device Via Percent of Error Accuracy of Respiration Rate | 90 minutes | 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. Assuming this binary result follows a binominal distribution, its confidence interval is also calculated. |
| Root Mean Squared Error (RMSE) of Respiration Rates From the CPM System vs Reference Device for Metronome Guided Breathing and Non-metronome Guided Breathing. | 90 minutes | 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 converted back to characterize a relative accuracy by taking an exponential of natural constant followed by subtraction of one. The RMS of residual error in % is characterized in this way because the linear fitting in the log-log domain and its residual errors represents faithful relative residual error regardless of an absolute value of TV. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance of CPM System's ECG by % of CPM ECG Strip Equivalent to Lead II Strip | device measurement (3 minutes) | Performance of CPM System's ECG is measurement by comparing CPM System ECG metrics to the reference device Lead II ECG strip. Clinicians reviewed the criteria below and decided if the CPM strip had equivalence to the Lead II strip. |
| ECG Accuracy Confirmation Comparing CPM Systems Generated ECG Metrics and Reference Lead II Generated ECG Metrics | device measurement (3 minutes) | Determine the accuracy of CPM System's ECG metrics to the reference device. Results are displayed as mean error with standard deviation of error. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Cohort The target population for this cohort is healthy adult volunteers who do not have preexisting heart or lung conditions or illness. The goal is to recruit a participant population with a range of body types and BMIs and an approximately even split of genders and compare the reference device measurements to the test device.
CPM Device: The CPM device and reference device are used simultaneous to validate the CPM device. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Healthy Cohort |
|---|---|
| Age, Continuous | 33.7 years STANDARD_DEVIATION 13.56 |
| BMI | 171.8 kg/m^2 STANDARD_DEVIATION 11.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Height | 171.8 centimeters STANDARD_DEVIATION 11.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 20 Participants |
| Weight | 82.7 kilograms STANDARD_DEVIATION 23.2 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Accuracy of CPM System Calculated RR Versus Reference Device Via Percent of Error Accuracy of Respiration Rate
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. Assuming this binary result follows a binominal distribution, its confidence interval is also calculated.
Time frame: 90 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Supine Position | Accuracy of CPM System Calculated RR Versus Reference Device Via Percent of Error Accuracy of Respiration Rate | 99.1 Percent |
| Upright Position | Accuracy of CPM System Calculated RR Versus Reference Device Via Percent of Error Accuracy of Respiration Rate | 98.5 Percent |
Primary
Root Mean Squared Error (RMSE) of Respiration Rates From the CPM System vs Reference Device for Metronome Guided Breathing and Non-metronome Guided Breathing.
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 converted back to characterize a relative accuracy by taking an exponential of natural constant followed by subtraction of one. The RMS of residual error in % is characterized in this way because the linear fitting in the log-log domain and its residual errors represents faithful relative residual error regardless of an absolute value of TV.
Time frame: 90 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Supine Position | Root Mean Squared Error (RMSE) of Respiration Rates From the CPM System vs Reference Device for Metronome Guided Breathing and Non-metronome Guided Breathing. | Root mean squared error for metronome guided breathing | 0.83 breath rates per minute (BRPM) |
| Supine Position | Root Mean Squared Error (RMSE) of Respiration Rates From the CPM System vs Reference Device for Metronome Guided Breathing and Non-metronome Guided Breathing. | Root mean squared error for non-metronome guided breathing | 1.03 breath rates per minute (BRPM) |
| Upright Position | Root Mean Squared Error (RMSE) of Respiration Rates From the CPM System vs Reference Device for Metronome Guided Breathing and Non-metronome Guided Breathing. | Root mean squared error for metronome guided breathing | 1.41 breath rates per minute (BRPM) |
| Upright Position | Root Mean Squared Error (RMSE) of Respiration Rates From the CPM System vs Reference Device for Metronome Guided Breathing and Non-metronome Guided Breathing. | Root mean squared error for non-metronome guided breathing | 0.97 breath rates per minute (BRPM) |
Secondary
ECG Accuracy Confirmation Comparing CPM Systems Generated ECG Metrics and Reference Lead II Generated ECG Metrics
Determine the accuracy of CPM System's ECG metrics to the reference device. Results are displayed as mean error with standard deviation of error.
Time frame: device measurement (3 minutes)
Population: For 29 participants, one ECG strip for CPM and one ECG strop for Lead II reference device were generated and compared.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Supine Position | ECG Accuracy Confirmation Comparing CPM Systems Generated ECG Metrics and Reference Lead II Generated ECG Metrics | Heart Rate (Beats per minute) | -0.2 milliseconds (ms) | Standard Error 2 |
| Supine Position | ECG Accuracy Confirmation Comparing CPM Systems Generated ECG Metrics and Reference Lead II Generated ECG Metrics | QRS witdh | 18.9 milliseconds (ms) | Standard Error 10.8 |
| Supine Position | ECG Accuracy Confirmation Comparing CPM Systems Generated ECG Metrics and Reference Lead II Generated ECG Metrics | QRS width (ms) excluding 8% of outliers | 17.4 milliseconds (ms) | Standard Error 9.6 |
| Supine Position | ECG Accuracy Confirmation Comparing CPM Systems Generated ECG Metrics and Reference Lead II Generated ECG Metrics | QT interval (ms) | 27.5 milliseconds (ms) | Standard Error 40.9 |
| Supine Position | ECG Accuracy Confirmation Comparing CPM Systems Generated ECG Metrics and Reference Lead II Generated ECG Metrics | QT interval (ms) excluding 8% of outliers | 20.3 milliseconds (ms) | Standard Error 33.1 |
| Supine Position | ECG Accuracy Confirmation Comparing CPM Systems Generated ECG Metrics and Reference Lead II Generated ECG Metrics | QTc interval | 27 milliseconds (ms) | Standard Error 37.6 |
| Supine Position | ECG Accuracy Confirmation Comparing CPM Systems Generated ECG Metrics and Reference Lead II Generated ECG Metrics | QTc interval excluding 8% f outliers | 20.4 milliseconds (ms) | Standard Error 30.7 |
Secondary
Performance of CPM System's ECG by % of CPM ECG Strip Equivalent to Lead II Strip
Performance of CPM System's ECG is measurement by comparing CPM System ECG metrics to the reference device Lead II ECG strip. Clinicians reviewed the criteria below and decided if the CPM strip had equivalence to the Lead II strip.
Time frame: device measurement (3 minutes)
Population: For 29 participants, a CPM lead strip and a Lead II ECG strip was generated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Supine Position | Performance of CPM System's ECG by % of CPM ECG Strip Equivalent to Lead II Strip | Quality QRS Presentation | 100 % of CPM Strips Equivalent to Lead II |
| Supine Position | Performance of CPM System's ECG by % of CPM ECG Strip Equivalent to Lead II Strip | QRS width measurability | 100 % of CPM Strips Equivalent to Lead II |
| Supine Position | Performance of CPM System's ECG by % of CPM ECG Strip Equivalent to Lead II Strip | Accurate Determination of QRS widening | 94 % of CPM Strips Equivalent to Lead II |
| Supine Position | Performance of CPM System's ECG by % of CPM ECG Strip Equivalent to Lead II Strip | QT interval measurability | 100 % of CPM Strips Equivalent to Lead II |
| Supine Position | Performance of CPM System's ECG by % of CPM ECG Strip Equivalent to Lead II Strip | A-Fib Rhythm Readability | 100 % of CPM Strips Equivalent to Lead II |