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

NCT ID: NCT06422364

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2024-05-22

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Weighted Wearable Blanket provided by Dreamland Baby Co.

Intervention Type: DEVICE

All infants will be placed in a weighted wearable blanket, provided by Dreamland Baby Co., and complete a nap polysomnogram.

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.

Group Type: EXPERIMENTAL

Weighted Wearable Blanket provided by Dreamland Baby Co.

Intervention Type: DEVICE

All infants will be placed in a weighted wearable blanket, provided by Dreamland Baby Co., and complete an overnight polysomnogram.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dreamland Baby Co.

UNKNOWN

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Harish Rao

Assistant Professor of Clinical Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Harish Rao, MD

Role: PRINCIPAL_INVESTIGATOR

Riley Hospital for Children at Indiana University Health

Locations

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

21638

Identifier Type: -

Identifier Source: org_study_id