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An Observational Study of Skin Reaction in Infants Using the Owlet Sock OSS 3.0
NCT05561946 · View on ClinicalTrials.gov ↗
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 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05561946
The ClinicalTrials.gov registry entry for NCT05561946 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Owlet Baby Care, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05561946 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Florida, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05561946?
The interventions under investigation include: Owlet OSS 3.0 (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05561946?
This trial is sponsored by Owlet Baby Care, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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