RecruitingNot Applicable

Accuracy Evaluation of the Owlet OSS 3.0-M1 Sensor in Toddlers and Preschoolers

United States90 participantsStarted 2025-12-15

Plain-language summary

The purpose of the study is to collect information from the Owlet OSS 3.0-M1 Sensor in toddlers and preschoolers to evaluate accuracy.

Who can participate

Age range

19 Months – 60 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject is between 19 months and ≤ 60 months of age.
. Subject's current body weight is ≥ 6 lbs.
. Subject/legal guardian is fluent in both written and spoken English.
. Subject is willing and able to follow study requirements
. Legal guardian has provided consent.

Exclusion criteria

. Subject has preexisting cardiovascular or respiratory disease or conditions.
. Subjects with abnormalities (e.g., limb deformities, open wounds, severe edema) at the planned application sites that would interfere with system measurements.
. The device(s) are unable to fit properly without risk of injury (e.g., hook of VELCRO is against the skin, wrap is too tight and constricting).
. Subject has skin irritation at the location of device placement.
. Subject has known allergies to adhesive.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pulse rate accuracy

Timeframe: 2 hours

SpO2 Accuracy

Timeframe: 2 hours

Trial details

NCT IDNCT07321938

SponsorOwlet Baby Care, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-31

View on ClinicalTrials.gov More Healthy trials