JessieHug Feasibility and Usability Assessment

NCT06466148 | Terminated FDA Device

• 1 other identifier: 23-08026420
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SIDS

Keywords

medical device; wearable medical device; infants

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Validating the clinical accuracy of the physiological parameters measured by the JessieHug (SpO2) against FDA-cleared reference devices.

  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.

  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.

  One session, up to 4 hours, during study period, up to 8 weeks.

Study Arms (3)

Newborn Cohort

EXPERIMENTAL

The JessieHug device will be placed on infants two times a week to determine usability, tolerability and safety. Clinical accuracy will be assessed in one inpatient (newborn cohort) or outpatient (2 month and 4 month cohorts) session.

Device: JessieHug

2 month Cohort

EXPERIMENTAL

The JessieHug device will be placed on infants two times a week to determine usability, tolerability and safety. Clinical accuracy will be assessed in one inpatient (newborn cohort) or outpatient (2 month and 4 month cohorts) session.

Device: JessieHug

4 month Cohort

EXPERIMENTAL

The JessieHug device will be placed on infants two times a week to determine usability, tolerability and safety. Clinical accuracy will be assessed in one inpatient (newborn cohort) or outpatient (2 month and 4 month cohorts) session.

Device: JessieHug

Interventions

JessieHug DEVICE

Assessment of JessieHug device when placed on infants.

2 month Cohort; 4 month Cohort; Newborn Cohort

Eligibility Criteria

• Age: 0 Months - 4 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy neonates and infants, with cohorts defined by the following age ranges:
• newborn (0 weeks and 0/7 days to 0 weeks and 5/7 days),
• month (6 weeks and 0/7 days to 11 weeks and 6/7 days),
• month (14 weeks and 0/7 days to 19 weeks and 6/7 days)
• Born after 37 0/7 weeks of pregnancy
• Parent or legal guardian at time of discharge is able to understand and provide consent for participation
• Parent or legal guardian at time of discharge is willing and able to participate in study procedures for the duration of the study
• Parent or legal guardian is fluent in English
• Parent or legal guardian has access to the internet

You may not qualify if:

• Low birth weight (\< 2500g)
• Any transfer out of the well baby nursery for increased level of care, including admission to the NICU or transitional nursery.
• Clinical indication for prolonged postnatal hospitalization (\>4 days)

Sponsors & Collaborators

• Empatica, Inc.: collaborator
• Weill Medical College of Cornell University: lead

Study Sites (1)

NewYork Presbyterian - Weill Cornell Medical Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Sudden Infant Death

Condition Hierarchy (Ancestors)

Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infant Death

Study Officials

• James M Kim, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 20, 2024
• Study Start: April 10, 2024
• Primary Completion: February 2, 2026
• Study Completion: February 2, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)