Respiration Validation for CPM Device

Cardiopulmonary Disease Clinical Trial

Official title:

Clinical Validation Study for Noninvasive Cardiopulmonary Management Device

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05445492
• Other study ID #: Resp CPM Validation Clayton
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 22, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: October 2023
• Source: Analog Device, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: November 1, 2023
• Est. primary completion date: August 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiopulmonary Disease
• Pulmonary Heart Disease

Intervention

Device:
• CPM Device
The CPM device and reference device are used simultaneous to validate the CPM device.

Locations

Country	Name	City	State
United States	Clayton Sleep Institute	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Analog Device, Inc.	Clayton Sleep Insititute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of CPM System calculated RR versus reference device	Proportion of the errors within ± 2bpm	Baseline
Primary	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	Baseline
Primary	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	Baseline
Secondary	Accuracy of CPM system calculated RR compared to reference device	Confirm that respiration rates of test device and reference device align	Baseline
Secondary	Skin temperature confirmation.	Confirm that ECG characteristics align with those from reference device	Baseline
Secondary	ECG confirmation.	Confirm that ECG readings align with those from reference device	Baseline