Clinical trial NCT06422364: Assessment of the Safety and Efficacy of Weighted Wearable Blankets in Healthy Infants During Sleep
Official title: Assessment of the Safety and Efficacy of Weighted Wearable Blankets in Healthy Infants During Sleep
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sleep
Keywords: Sleep
Healthy
Infant
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Dreamland Baby Co.
First posted: 2024-05-21
Enrollment: 7
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Heart Rate
timeFrame: Day 1, during polysomnogram, up to 8 hours
measure: Respiratory Rate
timeFrame: Day 1, during polysomnogram, up to 8 hours
measure: Body Temperature
timeFrame: Day 1, during polysomnogram, up to 8 hours
measure: Oxygen Saturation
timeFrame: Day 1, during polysomnogram, up to 8 hours
measure: Number of Infants with Observed Head Movement
timeFrame: Day 1, during polysomnogram, up to 8 hours
measure: Number of Infants with Observed Arm Movement
timeFrame: Day 1, during polysomnogram, up to 8 hours
measure: Number of Infants with Observed Body Movement
timeFrame: Day 1, during polysomnogram, up to 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children at Indiana University Health
state: Indiana
Study officials:
affiliation: Riley Hospital for Children at Indiana University Health
name: Harish Rao, MD
role: PRINCIPAL_INVESTIGATOR
References: