Monitoring Vital Signs With a Wireless Ingestible Device in Subjects Undergoing Polysomnography

Celero Systems, Inc.1 site in 1 country20 target enrollmentDecember 14, 2021

ConditionsSleep

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sleep
Sponsor: Celero Systems, Inc.
Enrollment: 20
Locations: 1
Primary Endpoint: Evaluate the ability of the VM Pill to monitor respiration from within the GI tract
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 14, 2021

End Date

October 31, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Celero Systems, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Evaluate the ability of the VM Pill to monitor respiration from within the GI tract

Time Frame: 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.