Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To collect respiration data via end-tidal CO2 and spirometry and compare respiration rates measured via the two methods.
This is a non-randomized, data collection study that will enroll up to 50 participants.
There will be one study visit per participant and no follow up period.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wearable respiration mask | Healthy control subjects not eligible for exercise. |
| |
| Wearable respiration mask - Exercise | Healthy control subjects eligible for exercise. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable Respiration mask - exercise | Device | Participants will be fitted for the respiration mask placed on their face to measure respiration data during rest and exercise. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory rate detection - end tidal CO2 | End-Tidal CO2 will be measured as a fractional concentration (volume percent of COâ‚‚ in exhaled gas). | From enrollment through the end of the data collection visit, expected to take up to 3 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory rate detection - spirometry | Spirometry will be measured as Forced Vital Capacity (FVC). | From enrollment through the data collection visit, up to 3 hours. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Healthy participants from the BSC employee population.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashley M Jensen, Masters of Science | Contact | 612-449-2918 | ashley.jensen@bsci.com | |
| Bin Mi, PhD | Contact | bin.mi@bsci.com |
| Name | Affiliation | Role |
|---|---|---|
| Kevin Chu, PhD | Boston Scientific Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Scientific Arden Hills | Recruiting | Saint Paul | Minnesota | 55014 | United States |
IPD will not be shared to concerns about privacy and confidentiality in a small study population.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Wearable respiration Mask | Device | Participants will be fitted for the respiration mask placed on their face to measure respiration data during rest. |
|