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NCT06422364 · ClinicalTrials.gov registry record · NA
Assessment of the Safety and Efficacy of Weighted Wearable Blankets in Healthy Infants During Sleep
A NA study, sponsored by Indiana University.
- Terminated
- Registry status
- NA
- Development phase
- 6
- Enrollment target
NCT06422364: Clinical Trial NA study, sponsored by Indiana University.
NCT06422364 is a NA study that was terminated before completion, run by Indiana University. The registered enrollment target is 6 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06422364, a NA study, was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to assess the risk of an infant overheating and/or experiencing lowered respiration via measurement of vital signs in a controlled clinical environment while wearing a weighted wearable blanket in male/female infant healthy volunteers, 0-12 months of age. The main questions it aims to answer are: Primary Objective: To pilot an investigation on the impact of weighted wearable blankets on vital signs and infant movement in healthy infants during nap polysomnogram. Secondary Objective: To investigate the efficacy of weighted wearable blankets on sleep patterns in healthy infants during overnight sleep.
Primary Outcome
Measured by EKG
Interventions
- DEVICE Weighted Wearable Blanket provided by Dreamland Baby Co.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2024-04-01 |
| Est. Completion | 2024-05-22 |
| Phase | NA |
Why NCT06422364 stopped before completion
NCT06422364 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Weighted Wearable Blanket provided by Dreamland Baby Co. is the first listed.
NCT06422364 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06422364 about?
NCT06422364 is a clinical study titled "Assessment of the Safety and Efficacy of Weighted Wearable Blankets in Healthy Infants During Sleep". The goal of this clinical trial is to assess the risk of an infant overheating and/or experiencing lowered respiration via measurement of vital signs in a controlled clinical environment while wearing a weighted wearable blanket in male/female infant healthy volunteers, 0-12 months of age. The main...
What is the current status of trial NCT06422364?
This trial is currently terminated. It is a NA study. The enrollment target is 6 participants. The study started on 2024-04-01. Estimated completion is 2024-05-22.
What interventions are being tested in trial NCT06422364?
The interventions under investigation include: Weighted Wearable Blanket provided by Dreamland Baby Co. (DEVICE).
Who is sponsoring clinical trial NCT06422364?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06422364's enrollment target sits among peer trials
6 1983rd of 2000 higher than 13 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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