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

NCT06422364 | Terminated Results DMC FDA Device

• 1 other identifier: 21638
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep

Keywords

Sleep; Healthy; Infant

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Efficacy of Weighted Wearable Blankets on Sleep Patterns in Healthy Infants During Overnight Sleep

  Day 1, during polysomnogram, up to 12 hours

Study Arms (2)

Nap Polysomnogram

EXPERIMENTAL

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.

Overnight Polysomnogram

EXPERIMENTAL

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.

Interventions

Weighted Wearable Blanket provided by Dreamland Baby Co. DEVICE

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

Nap Polysomnogram

Eligibility Criteria

• Age: 1 Day - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Dreamland Baby Co.: collaborator

Study Sites (1)

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

Results Point of Contact

• Title: Dr. Harish Rao, Assistant Professor of Clinical Pediatrics
• Organization: Indiana University

harirao@iu.edu

317-948-7208

Study Officials

• Harish Rao, MD

  Riley Hospital for Children at Indiana University Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Pediatrics

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 21, 2024
• Study Start: April 1, 2024
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: June 24, 2025
• Results First Posted: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)