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Clinical Trials/NCT05183529
NCT05183529
Completed
Not Applicable

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

Celero Systems, Inc.1 site in 1 country20 target enrollmentStarted: December 14, 2021Last updated:
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ConditionsSleep

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Celero Systems, Inc.
Enrollment
20
Locations
1
Primary Endpoint
Evaluate the ability of the VM Pill to monitor respiration from within the GI tract
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Device Feasibility
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Celero Systems, Inc.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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