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

Celero Systems, Inc.20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Sleep

Interventions

Vitals Monitoring Pill SystemDEVICE

The Celero Vitals Monitoring Pill (VM Pill) uses 3 axis accelerometry to measure physiological signals from within the GI tract.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

West Virginia University

Morgantown, West Virginia, United States

Outcomes

Primary Outcomes

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.

Time frame: During polysomnography

Data from ClinicalTrials.gov

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