NCT06422364

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 1 Day – 12 Months
• Healthy volunteers: Accepted

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.

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 age/weight/height, 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.

Conditions

• Sleep

Interventions

Type	Name	Description
DEVICE	Weighted Wearable Blanket provided by Dreamland Baby Co.	All infants will be placed in a weighted wearable blanket, provided by Dreamland Baby Co., and complete a nap polysomnogram.
DEVICE	Weighted Wearable Blanket provided by Dreamland Baby Co.	All infants will be placed in a weighted wearable blanket, provided by Dreamland Baby Co., and complete an overnight polysomnogram.

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-05-22
• Completion: 2024-05-22
• First posted: 2024-05-21
• Last updated: 2025-06-24
• Results posted: 2025-06-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study