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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 is a NA study that was terminated before completion, run by Indiana University. The registered enrollment target is 6 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06422364
The ClinicalTrials.gov registry entry for NCT06422364 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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