HealthyNCT07838402
Smart Sock Heart Rate Monitoring in Hospitalized Newborns
An observational study of Healthy and Newborn Infant, run by Tampere University Hospital at 1 site in Finland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 0 to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy, Newborn Infant
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- 30 Aug 2026to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Hospitalized full-term and late preterm newborn infants receiving care in the neonatal intensive care unit and observation unit at Tampere University Hospital, Finland.
Who may be able to join
- Hospitalized newborn infant
- Age <28 days
- Gestational age ≥35+0 weeks
- Birth weight ≥2 kg
- Parental informed consent
Who cannot join
- Known congenital heart disease
- Hospital-acquired infection
- Skin infection
- Lack of parental consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of a Smart Sock for Heart Rate Monitoring in Hospitalized Newborn Infants
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.
Read the detailed description
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.
- Conditions
- Healthy, Newborn Infant
- Keywords
- newborn infant, heart rate monitoring, wearable devices, neonatal monitoring, cardiac rhythm
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between heart rate measurements obtained from the smart sock and the standard patient monitor
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.
Measured: From initiation of smart sock monitoring through completion of the 12-16-hour monitoring period
Secondary outcomes (2)
Agreement in detection of rhythm abnormalities between the smart sock and the standard patient monitor
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.
Measured: From initiation of smart sock monitoring through completion of the 12-16-hour monitoring period
Parent- and healthcare professional-reported usability of the smart sock
Usability of the smart sock as assessed by parents and healthcare professionals using a questionnaire.
Measured: Immediately after completion of the 12-16-hour smart sock monitoring period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start30 Aug 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Owlet Baby Care, Inc.
- Responsible party
- Sponsor
- Investigators
- Tuija H Poutanen, MD, PhD, Principal investigator, Tampere University Hospital, Wellbeing Services County of PirkanmaaMerja Kallio, MD, PhD, Principal investigator, New Children's Hospital, Helsinki University Hospital and University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838402
- Sponsor's protocol ID
- R25059L
- Status last verified
- Sep 2026
- First submitted
- 20 Jul 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Smart Sock for Heart Rate Monitoring in Hospitalized Newborn Infants
- ClinicalTrials.gov ID
- NCT07838402
- Acronym / sponsor ID
- R25059L
- Conditions
- Healthy, Newborn Infant
- Keywords
- newborn infant, heart rate monitoring, wearable devices, neonatal monitoring, cardiac rhythm
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Owlet Baby Care, Inc.
- Study start
- 30 Aug 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Hospitalized full-term and late preterm newborn infants receiving care in the neonatal intensive care unit and observation unit at Tampere University Hospital, Finland.
Key inclusion criteria (5 listed)
- Hospitalized newborn infant
- Age <28 days
- Gestational age ≥35+0 weeks
- Birth weight ≥2 kg
- Parental informed consent
Key exclusion criteria (4 listed)
- Known congenital heart disease
- Hospital-acquired infection
- Skin infection
- Lack of parental consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 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
Parent- and healthcare professional-reported usability of the smart sock
Time frame: Immediately after completion of the 12-16-hour smart sock monitoring period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tuija H Poutanen, MD, PhD principal investigator
Tampere University Hospital, Wellbeing Services County of Pirkanmaa
Merja Kallio, MD, PhD principal investigator
New Children's Hospital, Helsinki University Hospital and University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Newborn Infant, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.