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

Not Applicable

Completed

• Conditions: Sleep

• Registration Number: NCT05183529
• Lead Sponsor: Celero Systems, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-14
• Study First Submitted: 2021-12-21
• Study First Submitted QC: 2021-12-21
• Study First Posted: 2022-01-10
• Primary Completion: 2023-09-30
• Study Completion: 2023-10-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States