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NCT06466148 · ClinicalTrials.gov registry record · NA
JessieHug Feasibility and Usability Assessment
A NA study of SIDS, sponsored by Weill Medical College of Cornell University.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06466148: Recruiting NA study of SIDS, sponsored by Weill Medical College of Cornell University.
NCT06466148 is a NA study of SIDS that is actively recruiting participants, run by Weill Medical College of Cornell University. The registered enrollment target is 50 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06466148, a NA study of SIDS, is actively recruiting participants, sponsored by Weill Medical College of Cornell University.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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
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.
Conditions Studied
Interventions
- DEVICE JessieHug
Study Locations (1)
New York
- NewYork Presbyterian - Weill Cornell Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-04-10 |
| Est. Completion | 2026-07-01 |
| Phase | NA |
What NCT06466148 shows while recruiting
NCT06466148 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 1 condition, with SIDS appearing as the primary indexed condition, and to 1 intervention - of which JessieHug is the first listed.
NCT06466148 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06466148 about?
NCT06466148 is a clinical study titled "JessieHug Feasibility and Usability Assessment". 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 new...
What is the current status of trial NCT06466148?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2024-04-10. Estimated completion is 2026-07-01.
What conditions does trial NCT06466148 study?
This clinical trial studies the following conditions: SIDS.
What interventions are being tested in trial NCT06466148?
The interventions under investigation include: JessieHug (DEVICE).
Who is sponsoring clinical trial NCT06466148?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06466148 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for SIDS
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06466148's enrollment target sits among peer trials
50 1279th of 2000 higher than 622 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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