Trial Outcomes & Findings for Assessment of the Safety and Efficacy of Weighted Wearable Blankets in Healthy Infants During Sleep (NCT NCT06422364)

NCT ID: NCT06422364

Last Updated: 2025-06-24

Results Overview

Measured by EKG

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: Day 1, during polysomnogram, up to 8 hours
• Results posted on: 2025-06-24

Participant Flow

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.

6 enrolled participants met inclusion criteria; 4 enrolled participants completed the nap polysomnogram; 2 enrolled participants were withdrawn due to study closure prior to scheduled overnight polysomnogram dates. Those that completed the nap polysomnogram also completed a one-week post survey.

Participant milestones

Measure	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.	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.
Overall Study STARTED	4	2
Overall Study COMPLETED	4	0
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	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.	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.
Overall Study Withdrawn due to study closure	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Nap Polysomnogram n=4 Participants 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.	Overnight Polysomnogram n=2 Participants 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.	Total n=6 Participants Total of all reporting groups
Age, Continuous	59 days STANDARD_DEVIATION 14.118545723032 • n=5 Participants	114.5 days STANDARD_DEVIATION 23.334523779156 • n=7 Participants	77.5 days STANDARD_DEVIATION 32.402160421799 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1, during polysomnogram, up to 8 hours

Population: The study was closed before participants could complete the overnight polysomnogram.

Measured by EKG

Outcome measures

Measure	Nap Polysomnogram n=4 Participants 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.	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.
Average Heart Rate	122 beats per minute Standard Deviation 18.98	—

PRIMARY outcome

Timeframe: Day 1, during polysomnogram, up to 8 hours

Population: The study was closed before participants could complete the overnight polysomnogram.

Measured by Respiratory effort belts

Outcome measures

Measure	Nap Polysomnogram n=4 Participants 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.	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.
Average Respiratory Rate	42.25 respirations per minute Standard Deviation 8.42	—

PRIMARY outcome

Timeframe: Day 1, during polysomnogram, up to 8 hours

Population: The study was closed before participants could complete the overnight polysomnogram.

Manually measured by ear thermometer

Outcome measures

Measure	Nap Polysomnogram n=4 Participants 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.	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.
Average Body Temperature	36.95 average body temperature, Celsius Standard Deviation 0.13	—

PRIMARY outcome

Timeframe: Day 1, during polysomnogram, up to 8 hours

Population: The study was closed before participants could complete the overnight polysomnogram.

Measured by pulse oximetry

Outcome measures

Measure	Nap Polysomnogram n=4 Participants 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.	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.
Average Oxygen Saturation	97.25 oxygen saturation percentage Standard Deviation 0.5	—

PRIMARY outcome

Timeframe: Day 1, during polysomnogram, up to 8 hours

Population: The study was closed before participants could complete the overnight polysomnogram.

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.

Outcome measures

Measure	Nap Polysomnogram n=4 Participants 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.	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.
Number of Infants With Observed Head Movement	4 Participants	—

PRIMARY outcome

Timeframe: Day 1, during polysomnogram, up to 8 hours

Population: The study was closed before participants could complete the overnight polysomnogram.

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.

Outcome measures

Measure	Nap Polysomnogram n=4 Participants 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.	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.
Number of Infants With Observed Arm Movement	1 Participants	—

PRIMARY outcome

Timeframe: Day 1, during polysomnogram, up to 8 hours

Population: The study was closed before participants could complete the overnight polysomnogram.

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.

Outcome measures

Measure	Nap Polysomnogram n=4 Participants 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.	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.
Number of Infants With Observed Body Movement	4 Participants	—

SECONDARY outcome

Timeframe: Day 1, during polysomnogram, up to 12 hours

Population: No overnight studies were completed; therefore, no data for this objective was collected.

The study was closed before any overnight studies were completed; therefore, no data for this objective was collected.

Outcome measures

Outcome data not reported

Adverse Events

Nap Polysomnogram

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Overnight Polysomnogram

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Nap Polysomnogram n=4 participants at risk 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.	Overnight Polysomnogram n=2 participants at risk 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.
Eye disorders Left Eye Discharge	25.0% 1/4 • Number of events 1 • 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. On the one-week post survey, parents were asked if their child had experienced any changes in their baseline health. If parent response was yes, parent was invited to describe what was experienced. A staff member then interviewed parent to collect adverse event information.	0.00% 0/2 • 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. On the one-week post survey, parents were asked if their child had experienced any changes in their baseline health. If parent response was yes, parent was invited to describe what was experienced. A staff member then interviewed parent to collect adverse event information.

Additional Information

Dr. Harish Rao, Assistant Professor of Clinical Pediatrics

Indiana University

Phone: 317-948-7208

Email: harirao@iu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place