Sleep Clinical Trial
Official title:
Monitoring Vital Signs With a Wireless Ingestible Device in Subjects Undergoing Polysomnography
NCT number | NCT05183529 |
Other study ID # | CIP-002 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | December 14, 2021 |
Est. completion date | October 2024 |
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | October 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Healthy individuals ages 18 - 65 inclusive who are indicated for a polysomnography study. Exclusion Criteria: - Patients with a history of abdominal surgery and/or any condition that may impact the GI tract, including but not limited to: - Constipation - Esophageal stricture - Esophagitis - Gastritis - Gastric ulcers - Peptic ulcer - Gallstones - Celiac Disease - Crohn's Disease - Ulcerative Colitis - Irritable Bowel Syndrome - Diverticulitis - Colorectal cancer |
Country | Name | City | State |
---|---|---|---|
United States | West Virginia University | Morgantown | West Virginia |
Lead Sponsor | Collaborator |
---|---|
Celero Systems, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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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