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

Celero Systems

Status: Completed

Conditions: Sleep

Treatments: Device: Vitals Monitoring Pill System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05183529

CIP-002

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Patients undergoing polysomnography

Experimental group

Treatment:

Device: Vitals Monitoring Pill System