Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422364
Status:
TERMINATED
Last Update Posted:
2024-06-28
First Post:
2024-04-26
Brief Title:
Assessment of the Safety and Efficacy of Weighted Wearable Blankets in Healthy Infants During Sleep
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Assessment of the Safety and Efficacy of Weighted Wearable Blankets in Healthy Infants During Sleep
Status:
TERMINATED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
External to study controversy has arisen around safety of the product Due to concerns raised by USCPSC and the AAP the PI has terminated site participation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to assess the risk of an infant overheating andor experiencing lowered respiration via measurement of vital signs in a controlled clinical environment while wearing a weighted wearable blanket in malefemale 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
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
Detailed Description:
To date there is no evaluation of the safety or efficacy of weighted wearable blankets on healthy infants during overnight use in the peer-reviewed scientific literature These are the conditions in which these products are used by consumers with infants sleeping unobserved throughout the night Given the rising popularity in the use of weighted wearable blankets in infants and the risk speculated a study of the potential impact of weighted wearable blankets on infant vital signs is warranted
Study Design Direct observational pilot study of the safety of weighted wearable blankets on a minimum 10 healthy infants aged 0-12 months with nap polysomnogram Participants will be placed in a weighted wearable blanket in accordance with their ageweightheight by their parent or caregiver under the supervision of a member of the study team After being put to sleep on their back the participant will remain in the weighted wearable blanket until completion of the nap polysomnogram
There are stopping parameters outlined elsewhere that will be used for this study If any of the stopping parameters are met the weighted blanket will be opened to assess if the weighted blanket is responsible for the change If determined yes the weighted blanket will be removed and the nap polysomnogram will be terminated
Study Design Direct observational pilot study of the safety of weighted wearable blankets on a minimum 10 healthy infants aged 0-12 months with nap polysomnogram Participants will be placed in a weighted wearable blanket in accordance with their ageweightheight by their parent or caregiver under the supervision of a member of the study team After being put to sleep on their back the participant will remain in the weighted wearable blanket until completion of the nap polysomnogram
There are stopping parameters outlined elsewhere that will be used for this study If any of the stopping parameters are met the weighted blanket will be opened to assess if the weighted blanket is responsible for the change If determined yes the weighted blanket will be removed and the nap polysomnogram will be terminated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None