JessieHug Feasibility and Usability Assessment
NCT Number: NCT06466148
Status: SUSPENDED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: SIDS
Interventions: DEVICE: JessieHug
Sponsor: Weill Medical College of Cornell University
Collaborators: Empatica, Inc.
Sex: ALL
Age: CHILD
Enrollment: 50
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-04-10
Completion Date: 2026-07-01
Locations: NewYork Presbyterian - Weill Cornell Medical Center, New York, New York, 10065, United States

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.

Primary Outcome Measures: Evaluating usability of the JessieHug measured by a System Usability Survey, Usability as measured by an average score of at least 68 out of 100 on the System Usability Survey (Lewis \& Sauro, 2018). Lowest possible score is 0 indicating low usability and highest possible score is 100 indicating high usability. Usability surveys will include questions related to ease of use, satisfaction, and confidence when interacting with the device., Every other week for through study completion (8 weeks)|Evaluating tolerability of the JessieHug measured by the Face, Legs, Activity, Cry, and Consolability Scale (FLACC) survey, which is an observer reported outcomes (ObsRO) survey., Tolerability as defined as a score of 5 or less on the FLACC. Lowest possible score is 0 indicating no pain and highest possible score is 10 indicating severe pain. The FLACC scale is a behavioral pain assessment scale, validated for use in children from 2 months to 7 years of age, that is used to assess pain in children who are unable to communicate their pain verbally (Voepel-Lewis et al., 1997)., Every week for through study completion (8 weeks)|Evaluating safety of the JessieHug assessed through a survey assessing adverse events and pain., The qualitative safety questionnaire assesses overall tolerability of the device, satisfaction of the caregiver for the tolerability of the device, pain or adverse reactions experienced, persistence of symptoms, and the degree any potential pain or adverse reactions interfered with daily activities or sleep., Every week for through study completion (8 weeks)|Percent caregiver completing all steps without errors, Ability of caregivers to follow provided instructions for unpacking and setting up the JessieHug device., At baseline
Secondary Outcome Measures: Validating the clinical accuracy of the physiological parameters measured by the JessieHug (SpO2) against FDA-cleared reference devices., Accuracy of the SpO2 algorithm outputs derived from JessieHug sensor data as measured by the Accuracy root-mean-square (Arms) difference between the JessieHug device measurements and the reference device measurements with passing criteria of 3.5% during no-motion conditions, respectively., One session, up to 4 hours, during study period, up to 8 weeks.|Validating the clinical accuracy of the physiological parameters measured by the JessieHug (pulse rate) against FDA-cleared reference devices., Accuracy of the pulse rate algorithm outputs derived from JessieHug sensor data as measured by the Accuracy root-mean-square (Arms) difference between the JessieHug device measurements and the reference device measurements with passing criteria of 3 beats per minute (bpm)during no-motion conditions, respectively ., One session, up to 4 hours, during study period, up to 8 weeks.|Validating the clinical accuracy of the physiological parameters measured by the JessieHug (respiratory rate) against FDA-cleared reference devices., Accuracy of the respiratory rate algorithm outputs derived from JessieHug sensor data as measured by the Accuracy root-mean-square (Arms) difference between the JessieHug device measurements and the reference device measurements with passing criteria of 3 breaths per minute (brpm) no-motion conditions, respectively., One session, up to 4 hours, during study period, up to 8 weeks.