SIDSNCT06466148
JessieHug Feasibility and Usability Assessment
A study testing JessieHug in people with SIDS, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- SIDS
- What is being tested?
- JessieHug
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2024to 2 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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),
- 2-month (6 weeks and 0/7 days to 11 weeks and 6/7 days),
- 4-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
Show all 9Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
NewYork Presbyterian - Weill Cornell Medical Center
New York, New York, 10065
About this study
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?
Read more
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.
Read the 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
- Being tested
- JessieHug
- Keywords
- medical device, wearable medical device, infants
- Medical subject headings
- Sudden Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JessieHugDevice
Assessment of JessieHug device when placed on infants.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: JessieHug |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: At baseline
Secondary outcomes (3)
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.
Measured: 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 .
Measured: 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.
Measured: One session, up to 4 hours, during study period, up to 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start10 Apr 2024
- Primary completion2 Feb 2026
- Study completion2 Feb 2026
Why it stopped: Low patient accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SIDSStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Empatica, Inc.
- Responsible party
- Sponsor
- Investigators
- James M Kim, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466148
- Sponsor's protocol ID
- 23-08026420
- Status last verified
- Apr 2026
- First submitted
- 12 Jun 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JessieHug Feasibility and Usability Assessment
- ClinicalTrials.gov ID
- NCT06466148
- Acronym / sponsor ID
- 23-08026420
- Conditions
- SIDS
- Keywords
- medical device, wearable medical device, infants
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low patient accrual.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Empatica, Inc.
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 20 Jun 2024 (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 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Newborn Cohort | Experimental | Device: JessieHugThe 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. |
| 2 month Cohort | Experimental | Device: JessieHugThe 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. |
| 4 month Cohort | Experimental | Device: JessieHugThe 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. |
Who may qualify
- Ages
- 0 to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Healthy neonates and infants, with cohorts defined by the following age ranges:
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JessieHugAssessment of JessieHug device when placed on infants. | Device | 2 month Cohort, 4 month Cohort, Newborn Cohort |
Primary outcome
Evaluating usability of the JessieHug measured by a System Usability Survey
Time frame: Every other week for through study completion (8 weeks)
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.
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.
Time frame: Every week for through study completion (8 weeks)
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).
Evaluating safety of the JessieHug assessed through a survey assessing adverse events and pain.
Time frame: Every week for through study completion (8 weeks)
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.
Percent caregiver completing all steps without errors
Time frame: At baseline
Ability of caregivers to follow provided instructions for unpacking and setting up the JessieHug device.
3 secondary outcomes
Validating the clinical accuracy of the physiological parameters measured by the JessieHug (SpO2) against FDA-cleared reference devices.
Time frame: 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.
Time frame: 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.
Time frame: One session, up to 4 hours, during study period, up to 8 weeks.
Results and safety
The study was stopped early (reason given: Low patient accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for SIDS
Enrolling by invitationPhase 2/3
An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007
Mucopolysaccharidosis II
Active, not recruitingPhase 2/3
A Multi-cohort Study of Safety, Efficacy, PK and PD of GNR-055 in Patients With Mucopolysaccharidosis Type II
Mucopolysaccharidosis Type II, Metabolic Diseases
Active, not recruitingPhase 2/3
A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronopathic (nMPS II) or Non-Neuronopathic Mucopolysaccharidosis Type II (nnMPS II)
Mucopolysaccharidosis II
RecruitingPhase 1
UCB Transplant of Inherited Metabolic Diseases With Administration of Intrathecal UCB Derived Oligodendrocyte-Like Cells
Adrenoleukodystrophy, Batten Disease
Not yet recruiting
Infant Safe Sleep in Pediatric Emergency Depratment
Infant Safe Sleep Practices, SIDS
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. This study is not recruiting at the moment.
James M Kim, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JessieHug in people with SIDS, run by Weill Medical College of Cornell University at 1 site in United States.
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 9 inclusion and 3 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: stopped early, as of the sponsor's last update on 27 Apr 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 United States. 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?
The study was stopped early (reason given: Low patient accrual.). Results are not available in the source record.
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?
Evaluating usability of the JessieHug measured by a System Usability Survey (time frame: Every other week for through study completion (8 weeks)). The study lists 4 primary outcomes in all. 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 27 Apr 2026.