Respiration Validation for CPM Device

Completed · Not applicable

Conditions studied: Cardiopulmonary Disease

In brief

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.

Key facts

Study ID

NCT05445492

Run by

Analog Device, Inc.

People needed

41

Starts

2022-06-22

Expected to finish

2022-08-11

Last updated by the study team

2024-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Clayton Sleep Institute — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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