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NCT05445492 · ClinicalTrials.gov registry record · NA
Respiration Validation for CPM Device
A NA study, sponsored by Analog Device.
- Completed
- Registry status
- NA
- Development phase
- 41
- Enrollment target
NCT05445492 is a NA study that has completed, run by Analog Device. The registered enrollment target is 41 participants.
The verdict
NCT05445492, a NA study, has completed, sponsored by Analog Device.
- COMPLETED
- Registry status
- NA
- Development phase
- 41 participants
- Enrollment target
Study 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
- DEVICE CPM Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2022-06-22 |
| Est. Completion | 2022-08-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05445492
The ClinicalTrials.gov registry entry for NCT05445492 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Analog Device, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CPM Device is the first listed.
NCT05445492 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05445492 about?
NCT05445492 is a clinical study titled "Respiration Validation for CPM Device". 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 va...
What is the current status of trial NCT05445492?
This trial is currently completed. It is a NA study. The enrollment target is 41 participants. The study started on 2022-06-22. Estimated completion is 2022-08-11.
What interventions are being tested in trial NCT05445492?
The interventions under investigation include: CPM Device (DEVICE).
Who is sponsoring clinical trial NCT05445492?
This trial is sponsored by Analog Device, which has 5 total clinical trials registered on ClinicalTrials.gov.
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