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

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.

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Key information

Conditions

Sleep

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Virginia University

Morgantown, West Virginia, 26506, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitals Monitoring Pill System

Device

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

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.

Sponsors and collaborators

Lead sponsor

Celero Systems, Inc.

Industry

Registry information

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Jan 10, 2022
Registry last updated: Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed