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

February 23, 2024 updated by: Celero Systems, Inc.
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University
        • Contact:
        • Principal Investigator:
          • Justin Kupec, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients undergoing polysomnography
Device: Vitals Monitoring Pill System
The Celero Vitals Monitoring Pill (VM Pill) uses 3 axis accelerometry to measure physiological signals from within the GI tract.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During polysomnography

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celero Systems, Inc.

Investigators

  • Principal Investigator: Justin Kupec, MD, West Virginia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2021

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

December 21, 2021

First Submitted That Met QC Criteria

December 21, 2021

First Posted (Actual)

January 10, 2022

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CIP-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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