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Behavioural Intervention

Weighted Blankets for Infant Sleep

N/A
Recruiting
Led By Harish Rao, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Weight greater than or equal to 8 pounds
0-12 months of age
Must not have
Weight < 8 pounds
Health status: medical diagnosis associated with underlying cardiac, neurological, or pulmonary disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, during polysomnogram, up to 8 hours
Awards & highlights

Summary

This trial aims to study the effects of using a weighted wearable blanket on vital signs, infant movement, and sleep patterns in healthy male and female infants aged 0-12 months. The primary goal is

Who is the study for?
This trial is for healthy infants, both male and female, aged between 0-12 months. The study aims to include babies who can safely participate in a controlled sleep environment. Specific eligibility criteria are not provided here.
What is being tested?
The trial is testing the safety and effectiveness of weighted wearable blankets made by Dreamland Baby Co. during infant sleep. It measures vital signs and movement during naps (polysomnogram) and assesses sleep patterns overnight.
What are the potential side effects?
Since this study involves healthy infants using weighted blankets, potential side effects might include overheating or changes in respiration rates; however, these will be closely monitored as part of the trial's safety assessment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh at least 8 pounds.
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I am a year old or younger.
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My baby is healthy without heart, brain, or lung problems.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My weight is less than 8 pounds.
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I have a heart, lung, or brain condition.
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I do not use cigarettes, vape, e-cigarettes, or marijuana at home.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, during polysomnogram, up to 8 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, during polysomnogram, up to 8 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body Temperature
Heart Rate
Number of Infants with Observed Arm Movement
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: PilotExperimental Treatment1 Intervention
Weighted wearable blanket, provided by Dreamland Baby Co.

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
997 Previous Clinical Trials
1,095,584 Total Patients Enrolled
1 Trials studying Sleep
300 Patients Enrolled for Sleep
Dreamland Baby Co.UNKNOWN
Harish Rao, MDPrincipal InvestigatorRiley Hospital for Children at Indiana University Health
~7 spots leftby Dec 2025
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