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Assessment of the Safety and Efficacy of Weighted Wearable Blankets in Healthy Infants During Sleep

Indiana University · 2024
ClinicalTrials.gov · Datasets · License: Public Domain · 2024
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healthyinfantnasleep
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.
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