NCT07321938

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2026

Completed
Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

December 22, 2025

Last Update Submit

January 6, 2026

Conditions

Healthy

Keywords

pulse oximetrypediatricsOwlet

Outcome Measures

Primary Outcomes (2)

  • Pulse rate accuracy

    Average root mean square (ARMS) error between the pulse rate measured by the Owlet OSS 3.0-M1 vs. a reference pulse oximeter

    2 hours

  • SpO2 Accuracy

    The average root mean square difference between the Owlet OSS 3.0-M1 Sensor vs. readints from an FDA cleared reference pulse oximeter.

    2 hours

Study Arms (1)

Owlet OSS 3.0-M1 Sensor

EXPERIMENTAL

Owlet OSS 3.0-M1 Sensor accuracy evaluation compared to a reference pulse oximeter.

Device: Application and monitoring with an Owlet OSS 3.0-M1 SensorDevice: Reference Pulse Oximeter

Interventions

Application and monitoring with an Owlet OSS 3.0-M1 SensorDEVICE

Owlet OSS 3.0-M1 Sensor

Owlet OSS 3.0-M1 Sensor
Reference Pulse OximeterDEVICE

Application and monitoring with an FDA cleared reference pulse oximeter

Owlet OSS 3.0-M1 Sensor

Eligibility Criteria

Age19 Months - 60 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vital Signs Research Group, LLC

San Francisco, California, 94107, United States

RECRUITING

Study Officials

  • Greg Stratmann, MD, PhD

    Vital Signs Research Group, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Prospective study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2025

First Posted

January 7, 2026

Study Start

December 15, 2025

Primary Completion

March 31, 2026

Study Completion

April 28, 2026

Last Updated

January 7, 2026

Record last verified: 2026-01

Locations

US(1)