NCT06466148

JessieHug Feasibility and Usability Assessment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 0 Months – 4 Months
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluates the usability, tolerability, and clinical accuracy of the JessieHug device, a wearable medical device for newborns and infants that collects physiological data. The main questions it aims to answer are: * Is the device easily usable for parents of newborns and infants? * Is the device tolerable when worn by infants and are there any safety concerns? * Is the device able to collect clinically accurate physiologic data compared to a FDA-cleared reference device? Participants will: * Place the JessieHug device on their infant two times a week and complete surveys to assess usability, tolerability and safety. * Have one session where the JessieHug device will be worn at the same time as reference device to determine accuracy.

Detailed description

This study evaluates the usability, tolerability, and clinical accuracy of the JessieHug device, a wearable medical device for newborns and infants that continuously collects physiological data. Three cohorts of infants will be enrolled: newborn, 2-month, and 4-month groups, with each cohort undergoing data collection over a total of eight (8) weeks. The JessieHug device will be assessed for usability and tolerability through parental surveys while the baby wears the device in home and hospital settings. Clinical accuracy of the device will be evaluated through comparison to an FDA cleared reference device in a single outpatient clinic-based data collection event.

Conditions

• SIDS

Interventions

Type	Name	Description
DEVICE	JessieHug	Assessment of JessieHug device when placed on infants.

Timeline

• Start date: 2024-04-10
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-06-20
• Last updated: 2025-05-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study