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An Observational Study of Skin Reaction in Infants Using the Owlet Sock OSS 3.0

NCT05561946 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 43

Last updated 2022-09-30

No results posted yet for this study

Summary

This multi-center, open-label, observational study will evaluate possible skin reactions associated with the wearing of the Owlet OSS 3.0 device continuously (except during sensor charging and excessive motion) up to 24 hours per day in a clinical environment.

Conditions

  • Skin Injury

Interventions

DEVICE

Owlet OSS 3.0

The Owlet OSS 3.0 is worn continuously for a minimum of 48 hours and the skin where the device is worn is monitored for any skin injury/irritation

Sponsors & Collaborators

  • Louisiana State University Health Sciences Center Shreveport

    collaborator OTHER

  • University of Utah

    collaborator OTHER

  • Topaz Clinical Research

    collaborator UNKNOWN

  • Owlet Baby Care, Inc.

    lead INDUSTRY

Principal Investigators

  • Alisa Niksch, MD · Study Sponsor

Eligibility

Min Age
44 Weeks
Max Age
18 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-21
Primary Completion
2022-08-04
Completion
2022-08-24

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05561946 on ClinicalTrials.gov