## Protocol Section
### Identification Module
**NCT ID:** NCT06422364

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 21638
#### Organization
**Class:** OTHER
**Full Name:** Indiana University
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-26
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Dreamland Baby Co.

#### Lead Sponsor

**Class:** OTHER

**Name:** Indiana University

#### Responsible Party

**Investigator Affiliation:** Indiana University

**Investigator Full Name:** Harish Rao

**Investigator Title:** Assistant Professor of Clinical Pediatrics

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is Unapproved Device:** True

**Oversight Has DMC:** True

### Description Module

**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.

Secondar 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.

### Conditions Module

**Conditions:**

- Sleep

**Keywords:**

- Sleep

- Healthy

- Infant

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 10

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Weighted wearable blanket, provided by Dreamland Baby Co.

**Intervention Names:**

- Device: Weighted Wearable Blanket provided by Dreamland Baby Co.

**Label:** Pilot

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Pilot

**Description:** All infants will be placed in a weighted wearable blanket, provided by Dreamland Baby Co., and complete a nap polysomnogram.

**Name:** Weighted Wearable Blanket provided by Dreamland Baby Co.

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Measured by EKG

**Measure:** Heart Rate

**Time Frame:** Day 1, during polysomnogram, up to 8 hours

**Description:** Measured by Respiratory effort belts

**Measure:** Respiratory Rate

**Time Frame:** Day 1, during polysomnogram, up to 8 hours

**Description:** Manually measured by ear thermometer

**Measure:** Body Temperature

**Time Frame:** Day 1, during polysomnogram, up to 8 hours

**Description:** Measured by pulse oximetry

**Measure:** Oxygen Saturation

**Time Frame:** Day 1, during polysomnogram, up to 8 hours

**Description:** 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.

**Measure:** Number of Infants with Observed Head Movement

**Time Frame:** Day 1, during polysomnogram, up to 8 hours

**Description:** 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.

**Measure:** Number of Infants with Observed Arm Movement

**Time Frame:** Day 1, during polysomnogram, up to 8 hours

**Description:** 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.

**Measure:** Number of Infants with Observed Body Movement

**Time Frame:** Day 1, during polysomnogram, up to 8 hours

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 12 Months

**Minimum Age:** 1 Day

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** lashivel@iu.edu

**Name:** Lori Trotter, RN

**Phone:** 317-278-7121

**Role:** CONTACT

**Contact 2:**

**Email:** lbendy@iu.edu

**Name:** Lisa Bendy, BA

**Phone:** 317-278-7152

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Indianapolis

**Contacts:**

***Contact 1:***

- **Name:** Harish Rao, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Riley Hospital for Children at Indiana University Health

**State:** Indiana

**Status:** RECRUITING

**Zip:** 46202

#### Overall Officials

**Official 1:**

**Affiliation:** Riley Hospital for Children at Indiana University Health

**Name:** Harish Rao, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5114

- Name: Body Weight

- Relevance: HIGH

- As Found: Weighted

### Condition Browse Module - Meshes

- ID: D000001835

- Term: Body Weight

### Misc Info Module

- Version Holder: 2024-05-31
