MedTrace Logo

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

NCT06422364 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-06-24

Study results available
· View outcomes & findings →

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

Interventions

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.

Sponsors & Collaborators

  • Dreamland Baby Co.

    collaborator UNKNOWN

  • Indiana University

    lead OTHER

Principal Investigators

  • Harish Rao, MD · Riley Hospital for Children at Indiana University Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2024-05-22
Completion
2024-05-22
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06422364 on ClinicalTrials.gov