Respiration Validation for CPM Device
Primary Purpose
Cardiopulmonary Disease
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CPM Device
Sponsored by
About this trial
This is an interventional diagnostic trial for Cardiopulmonary Disease
Eligibility Criteria
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)
Sites / Locations
- Clayton Sleep Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Healthy Cohort
Arm Description
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.
Outcomes
Primary Outcome Measures
Accuracy of CPM System calculated RR versus reference device
Proportion of the errors within ± 2bpm
Accuracy of the changes in the rTV calculated by CPM System compared to reference TV, if data is available.
Root Mean Squared (RMS) of residual relative error after linear fitting
Accuracy of the changes in the rTV calculated by CPM System compared to reference TV, if data is available.
Correlation coefficient between reference device's TV and test device's rTV within subjects
Secondary Outcome Measures
Accuracy of CPM system calculated RR compared to reference device
Confirm that respiration rates of test device and reference device align
Skin temperature confirmation.
Confirm that ECG characteristics align with those from reference device
ECG confirmation.
Confirm that ECG readings align with those from reference device
Full Information
NCT ID
NCT05445492
First Posted
June 30, 2022
Last Updated
October 5, 2023
Sponsor
Analog Device, Inc.
Collaborators
Clayton Sleep Insititute
1. Study Identification
Unique Protocol Identification Number
NCT05445492
Brief Title
Respiration Validation for CPM Device
Official Title
Clinical Validation Study for Noninvasive Cardiopulmonary Management Device
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 22, 2022 (Actual)
Primary Completion Date
August 4, 2022 (Actual)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Analog Device, Inc.
Collaborators
Clayton Sleep Insititute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopulmonary Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Non-randomized control trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy Cohort
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CPM Device
Intervention Description
The CPM device and reference device are used simultaneous to validate the CPM device.
Primary Outcome Measure Information:
Title
Accuracy of CPM System calculated RR versus reference device
Description
Proportion of the errors within ± 2bpm
Time Frame
Baseline
Title
Accuracy of the changes in the rTV calculated by CPM System compared to reference TV, if data is available.
Description
Root Mean Squared (RMS) of residual relative error after linear fitting
Time Frame
Baseline
Title
Accuracy of the changes in the rTV calculated by CPM System compared to reference TV, if data is available.
Description
Correlation coefficient between reference device's TV and test device's rTV within subjects
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Accuracy of CPM system calculated RR compared to reference device
Description
Confirm that respiration rates of test device and reference device align
Time Frame
Baseline
Title
Skin temperature confirmation.
Description
Confirm that ECG characteristics align with those from reference device
Time Frame
Baseline
Title
ECG confirmation.
Description
Confirm that ECG readings align with those from reference device
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Clayton Sleep Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63123
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Respiration Validation for CPM Device
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