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

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06422364
• Other study ID #: 21638
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Indiana University
• Contact: Lori Trotter, RN
• Phone: 317-278-7121
• Email: lashivel[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Secondar Objective: To investigate the efficacy of weighted wearable blankets on sleep patterns in healthy infants during overnight sleep.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 12 Months

Eligibility

Inclusion Criteria:

• Ability of parent, caregiver or legal guardian/representative to understand a written informed consent document and choose to participate in the study

• 0-12 months of age

• Weight greater than or equal to 8 pounds

• Gestational age 37 weeks or greater

• Health status: healthy infant without underlying cardiac, neurological, or pulmonary disorders

• Infant is naive to a weighted wearable blanket

Exclusion Criteria:

• Health status: medical diagnosis associated with underlying cardiac, neurological, or pulmonary disorder

• Weight < 8 pounds

• Gestational age < 37 weeks

• Gestational use of marijuana, alcohol, or illicit drugs

• Home environment: use of cigarettes, vaping, e-cigarettes, or marijuana

• Infant is not naive to a weighted wearable blanket

Related Conditions & MeSH terms

• Body Weight
• Sleep

Intervention

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.

Locations

Country	Name	City	State
United States	Riley Hospital for Children at Indiana University Health	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Dreamland Baby Co.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate	Measured by EKG	Day 1, during polysomnogram, up to 8 hours
Primary	Respiratory Rate	Measured by Respiratory effort belts	Day 1, during polysomnogram, up to 8 hours
Primary	Body Temperature	Manually measured by ear thermometer	Day 1, during polysomnogram, up to 8 hours
Primary	Oxygen Saturation	Measured by pulse oximetry	Day 1, during polysomnogram, up to 8 hours
Primary	Number of Infants with Observed Head Movement	The clinical technician will be asked to report any observed infant movements during the polysomnogram. The technician will report either Yes or No to this question.	Day 1, during polysomnogram, up to 8 hours
Primary	Number of Infants with Observed Arm Movement	The clinical technician will be asked to report any observed infant movements during the polysomnogram. The technician will report either Yes or No to this question.	Day 1, during polysomnogram, up to 8 hours
Primary	Number of Infants with Observed Body Movement	The clinical technician will be asked to report any observed infant movements during the polysomnogram. The technician will report either Yes or No to this question.	Day 1, during polysomnogram, up to 8 hours