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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06422364

Enrollment

Registered

2024-05-21

Start date

2024-04-01

Completion date

2024-05-22

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep

Keywords

Sleep, Healthy, Infant

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.

Detailed description

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.

Interventions

DEVICEWeighted 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Days to 12 Months

Healthy volunteers

Yes

Inclusion criteria

* Ability of parent, caregiver or legal guardian/representative to understand a written informed consent document and choose to participate in the study * 0-12 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Number of Infants With Observed Body Movement	Day 1, during polysomnogram, up to 8 hours	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.
Average Heart Rate	Day 1, during polysomnogram, up to 8 hours	Measured by EKG
Average Respiratory Rate	Day 1, during polysomnogram, up to 8 hours	Measured by Respiratory effort belts
Average Body Temperature	Day 1, during polysomnogram, up to 8 hours	Manually measured by ear thermometer
Average Oxygen Saturation	Day 1, during polysomnogram, up to 8 hours	Measured by pulse oximetry
Number of Infants With Observed Head Movement	Day 1, during polysomnogram, up to 8 hours	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.
Number of Infants With Observed Arm Movement	Day 1, during polysomnogram, up to 8 hours	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.

Secondary

Measure	Time frame	Description
Efficacy of Weighted Wearable Blankets on Sleep Patterns in Healthy Infants During Overnight Sleep	Day 1, during polysomnogram, up to 12 hours	The study was closed before any overnight studies were completed; therefore, no data for this objective was collected.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

Arm	Count
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.	4
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.	2
Total	6

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Withdrawn due to study closure	0	2

Baseline characteristics

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

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 4	0 / 2
other Total, other adverse events	1 / 4	0 / 2
serious Total, serious adverse events	0 / 4	0 / 2

Outcome results

Primary