Smart Sock Heart Rate Monitoring in Hospitalized Newborns

The goal of this observational study is to evaluate a commercially available smart sock for heart rate monitoring in hospitalized newborn infants without known heart disease. The study aims to determine whether the smart sock provides heart rate information comparable to that obtained from the standard patient monitor used in routine neonatal care.

The main questions this study aims to answer are:

* Does the smart sock provide heart rate measurements comparable to those obtained from the standard patient monitor? * Does the smart sock provide comparable information on clinically relevant rhythm abnormalities? * How do parents and healthcare professionals perceive the usability and safety of the smart sock? Participants will wear the smart sock while undergoing routine monitoring on the neonatal ward. Heart rate and rhythm data from the smart sock will be compared with data from the standard patient monitor. Parents and healthcare professionals will provide feedback on the usability and perceived safety of the device.

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Key information

Conditions

Healthy Newborn Infant

Age range

0 day–28 day

Sex eligibility

All sexes

Study type

Observational

About this study

Commercially available wearable monitoring devices for infants are increasingly used, but evidence on their performance in hospitalized newborns is limited. This study evaluates the accuracy and usability of the Owlet Dream Sock™ in hospitalized newborn infants. Heart rate and rhythm data obtained from the smart sock will be compared with data from the standard patient monitor used in routine neonatal care. In addition, parents and healthcare professionals will evaluate the usability and perceived safety of the device.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Hospitalized newborn infant
Age <28 days
Gestational age ≥35+0 weeks
Birth weight ≥2 kg
Parental informed consent

Exclusion criteria

Known congenital heart disease
Hospital-acquired infection
Skin infection
Lack of parental consent

Treatment and study plan

Primary outcomes

Agreement between heart rate measurements obtained from the smart sock and the standard patient monitor

Time frame: From initiation of smart sock monitoring through completion of the 12-16-hour monitoring period

Heart rate data obtained from the smart sock will be compared with simultaneous heart rate data obtained from the standard patient monitor used in routine neonatal care.

Secondary outcomes

Agreement in detection of rhythm abnormalities between the smart sock and the standard patient monitor

Time frame: From initiation of smart sock monitoring through completion of the 12-16-hour monitoring period

Rhythm abnormalities and rhythm-related alarms identified by the standard patient monitor will be reviewed and compared with data obtained from the smart sock to assess the ability of the smart sock to detect clinically significant rhythm abnormalities lasting >3 minutes.
Parent- and healthcare professional-reported usability of the smart sock

Time frame: Immediately after completion of the 12-16-hour smart sock monitoring period

Usability of the smart sock as assessed by parents and healthcare professionals using a questionnaire.

Study contacts

Contact information is provided by the study sponsor or research team.

Kirsi Ylä-Tuuhonen, MD

CONTACT

[email protected]

+358 44 472 8190

Minna Mecklin, MD, PhD

CONTACT

[email protected]

+358 44 472 8153

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

Owlet Baby Care, Inc.

Registry information

Official study title

Evaluation of a Smart Sock for Heart Rate Monitoring in Hospitalized Newborn Infants

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Sep 24, 2026
Registry last updated: Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Not yet recruiting