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 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.

Study Overview

• Status: Terminated
• Conditions: Sleep
• Intervention / Treatment: Device: Weighted Wearable Blanket provided by Dreamland Baby Co.; Device: Weighted Wearable Blanket provided by Dreamland Baby Co.

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Hospital for Children at Indiana University Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nap Polysomnogram; All healthy infants under 3 months of age that met inclusion criteria were assigned to complete a nap polysomnogram while wearing a weighted wearable blanket provided by Dreamland Baby Co.	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.
Experimental: Overnight Polysomnogram; All healthy infants over 3 months of age that met inclusion criteria were assigned to complete an overnight polysomnogram while wearing a weighted wearable blanket provided by Dreamland Baby Co.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Heart Rate	Measured by EKG	Day 1, during polysomnogram, up to 8 hours
Average Respiratory Rate	Measured by Respiratory effort belts	Day 1, during polysomnogram, up to 8 hours
Average Body Temperature	Manually measured by ear thermometer	Day 1, during polysomnogram, up to 8 hours
Average Oxygen Saturation	Measured by pulse oximetry	Day 1, during polysomnogram, up to 8 hours
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Weighted Wearable Blankets on Sleep Patterns in Healthy Infants During Overnight Sleep	The study was closed before any overnight studies were completed; therefore, no data for this objective was collected.	Day 1, during polysomnogram, up to 12 hours

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Dreamland Baby Co.
• Investigators: Principal Investigator: Harish Rao, MD, Riley Hospital for Children at Indiana University Health

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): May 22, 2024
• Study Completion (Actual): May 22, 2024

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 21, 2024

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Healthy; Sleep; Infant
• Additional Relevant MeSH Terms: Body Weight
• Other Study ID Numbers: 21638

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes