An interventional study of Weighted Wearable Blanket provided by Dreamland Baby Co. and Weighted Wearable Blanket provided by Dreamland Baby Co. in Sleep, sponsored by Indiana University. Terminated at 1 site in United States. Open to participants aged 1 Day to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-24.
Sponsored by Indiana University · Not applicable, Interventional, and Other
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.
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.
Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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.
All infants will be placed in a weighted wearable blanket, provided by Dreamland Baby Co., and complete an overnight polysomnogram.
Average Heart Rate
Measured by EKG
Time frame: Day 1, during polysomnogram, up to 8 hours
Average Respiratory Rate
Measured by Respiratory effort belts
Time frame: Day 1, during polysomnogram, up to 8 hours
Average Body Temperature
Manually measured by ear thermometer
Time frame: Day 1, during polysomnogram, up to 8 hours
Average Oxygen Saturation
Measured by pulse oximetry
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1, during polysomnogram, up to 8 hours
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.
Time frame: Day 1, during polysomnogram, up to 12 hours
The Dreamland Baby website utilized a link for potential participants to express their interest in the study. A member of the study team made contact by email and then telephone to conduct a recruitment/screening questionnaire. A nap polysomnogram was scheduled during daytime hours for participants that met inclusion criteria and were under 3 months of age. Infants that met inclusion criteria and were greater than 3 months of age were scheduled for an overnight polysomnogram.
| Milestone | Nap Polysomnogram | Overnight Polysomnogram |
|---|---|---|
| Started | 4 | 2 |
| Completed | 4 | 0 |
| Not completed | 0 | 2 |
| Withdrew: Withdrawn due to study closure | 0 | 2 |
Measured by EKG
| beats per minute | Nap Polysomnogram | Overnight Polysomnogram |
|---|---|---|
| Average Heart Rate | 122 ± 18.98 | — |
Measured by Respiratory effort belts
| respirations per minute | Nap Polysomnogram | Overnight Polysomnogram |
|---|---|---|
| Average Respiratory Rate | 42.25 ± 8.42 | — |
Manually measured by ear thermometer
| average body temperature, Celsius | Nap Polysomnogram | Overnight Polysomnogram |
|---|---|---|
| Average Body Temperature | 36.95 ± 0.13 | — |
Measured by pulse oximetry
| oxygen saturation percentage | Nap Polysomnogram | Overnight Polysomnogram |
|---|---|---|
| Average Oxygen Saturation | 97.25 ± 0.5 | — |
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.
| Participants | Nap Polysomnogram | Overnight Polysomnogram |
|---|---|---|
| Number of Infants With Observed Head Movement | 4 | — |
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.
| Participants | Nap Polysomnogram | Overnight Polysomnogram |
|---|---|---|
| Number of Infants With Observed Arm Movement | 1 | — |
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.
| Participants | Nap Polysomnogram | Overnight Polysomnogram |
|---|---|---|
| Number of Infants With Observed Body Movement | 4 | — |
The study was closed before any overnight studies were completed; therefore, no data for this objective was collected.
No measurements were reported for this outcome.
Collected over Adverse event data was collected after informed consent was signed until the one-week post survey was completed. The maximum amount of time participants spent in the study was 37 days, which included signing the informed consent, completing the nap polysomnogram and completing the one-week post survey.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nap Polysomnogram | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) |
| Overnight Polysomnogram | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Event | Nap Polysomnogram | Overnight Polysomnogram |
|---|---|---|
| Left Eye DischargeEye disorders | 1/4 | 0/2 |
| Age, Continuous(days) | Nap Polysomnogram | Overnight Polysomnogram | Total |
|---|---|---|---|
| Mean | 59 ± 14.118545723032 | 114.5 ± 23.334523779156 | 77.5 ± 32.402160421799 |
| Sex: Female, Male(Participants) | Nap Polysomnogram | Overnight Polysomnogram | Total |
|---|---|---|---|
| Female | 2 | 1 | 3 |
| Male | 2 | 1 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Nap Polysomnogram | Overnight Polysomnogram | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 4 | 2 | 6 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Nap Polysomnogram | Overnight Polysomnogram | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 3 | 2 | 5 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
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