Sleep
Conditions
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.
Interventions
DEVICEVitals Monitoring Pill System
The Celero Vitals Monitoring Pill (VM Pill) uses 3 axis accelerometry to measure physiological signals from within the GI tract.
Sponsors
Celero Systems, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed