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This Minimal Risk study is designed to evaluate the ability of the Celero ingestible Vitals Monitoring Pill (i.e., VM Pill) to measure respiration from within the gastrointestinal tract, in addition to performing an exploratory comparative analysis of data collected by the VM Pill and data collected from clinical monitoring sensors as part of polysomnography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing polysomnography | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitals Monitoring Pill System | Device | The Celero Vitals Monitoring Pill (VM Pill) uses 3 axis accelerometry to measure physiological signals from within the GI tract. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the ability of the VM Pill to monitor respiration from within the GI tract | Mean absolute error between respiratory rate measured by the VM Pill and respiratory rate measured by PSG monitoring equipment during periods of normal breathing while the patient is sleeping or at rest. | During polysomnography |
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Inclusion Criteria:
Exclusion Criteria:
Patients with a history of abdominal surgery and/or any condition that may impact the GI tract, including but not limited to:
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| Name | Affiliation | Role |
|---|---|---|
| Justin Kupec, MD | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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