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NCT05561946 · ClinicalTrials.gov registry record
An Observational Study of Skin Reaction in Infants Using the Owlet Sock OSS 3.0
A clinical trial of Skin Injury, sponsored by Owlet Baby Care.
- Completed
- Registry status
- 43
- Enrollment target
- 2
- Study locations
NCT05561946: Completed study of Skin Injury, sponsored by Owlet Baby Care.
NCT05561946 is a study of Skin Injury that has completed, run by Owlet Baby Care. The registered enrollment target is 43 participants. The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05561946, a study of Skin Injury, has completed, sponsored by Owlet Baby Care.
- COMPLETED
- Registry status
- 43 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
To estimate the incidence of clinically important skin reactions associated with the Owlet Sock OSS 3.0 when instructions for use are followed.
Conditions Studied
Interventions
- DEVICE Owlet OSS 3.0
Study Locations (2)
Florida
- TOPAZ Clinical Research - Apopka
Louisiana
- Louisiana State University Health Shreveport - Shreveport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2021-12-21 |
| Est. Completion | 2022-08-24 |
What the finished NCT05561946 record still lists
NCT05561946 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 43 participants, a relatively small participant target.
The record links to 1 condition, with Skin Injury appearing as the primary indexed condition, and to 1 intervention - of which Owlet OSS 3.0 is the first listed.
NCT05561946 reports a single indexed study location in Florida, Louisiana.
Frequently Asked Questions
What is clinical trial NCT05561946 about?
NCT05561946 is a clinical study titled "An Observational Study of Skin Reaction in Infants Using the Owlet Sock OSS 3.0". 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.
What is the current status of trial NCT05561946?
This trial is currently completed. The enrollment target is 43 participants. The study started on 2021-12-21. Estimated completion is 2022-08-24.
What conditions does trial NCT05561946 study?
This clinical trial studies the following conditions: Skin Injury.
What interventions are being tested in trial NCT05561946?
The interventions under investigation include: Owlet OSS 3.0 (DEVICE).
Who is sponsoring clinical trial NCT05561946?
This trial is sponsored by Owlet Baby Care, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05561946 being conducted?
This trial has 2 study locations across Florida, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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