Monitoring Vital Signs With a Wireless Ingestible Device in Subjects Undergoing Polysomnography
- Conditions
- Sleep
- Interventions
- Device: Vitals Monitoring Pill System
- Registration Number
- NCT05183529
- Lead Sponsor
- Celero Systems, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Healthy individuals ages 18 - 65 inclusive who are indicated for a polysomnography study.
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients undergoing polysomnography Vitals Monitoring Pill System -
- Primary Outcome Measures
Name Time Method Evaluate the ability of the VM Pill to monitor respiration from within the GI tract During polysomnography 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
West Virginia University
🇺🇸Morgantown, West Virginia, United States