Assessment of the Safety and Efficacy of Weighted Wearable Blankets in Healthy Infants During Sleep
Phase: NA
Conditions: Sleep
Sponsor: Indiana University

IRB# 21638 
Document Date: 20Feb2024 (Initial submission)  
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Assessment of the Safety and Efficacy of Weighted Wearable 
Blankets in Healthy Infants During Sleep 
 
Principal Investigator 
Harish Rao, MD, MRCPCH 
Assistant Professor 
Phone: 347-296-6013 
Email: harirao@iu.edu 
 
 
Co-Investigators 
Hasnaa Jalou, MD 
Associate Professor 
Email: hjalou@iu.edu 
 
Anuja Bandyopadhyay, MBBS 
Assistant Professor 
Email: anubandy@iupui.edu 
 
 
 
Division of Pediatric Pulmonology, Allergy and Sleep Medicine 
Indiana University School of Medicine and 
Riley Hospital for Children at Indiana University Health 
 
 

IRB# 21638 
Document Date: 20Feb2024 (Initial submission)  
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Background & Rationale 
Approximately 3.6 million infants are born in the United States each year according to CDC 
data, and sleep plays a critical role in their overall health and development. Sleep impacts infant 
physical growth, brain development, emotional well-being, physical health, feeding/digestion, 
and regulation of biological rhythms1. Parents/caregivers play a crucial role in creating a safe and 
comfortable sleep environment for infants, vital for infant well-being, but also providing space 
for caregivers to get the rest that they need. Despite this importance, a survey from Owlet Baby 
Care found that nearly half of all parents with children 6 months or younger get just 1-3 hours of 
uninterrupted sleep a night. Weighted wearable blankets have gained popularity in recent years 
due to their potential benefits in promoting better sleep and relaxation. Some key potential 
benefits include: deep pressure stimulation, a calming effect, enhanced sleep and sleep quality, 
and reduced restlessness. Parents are utilizing weighted wearable blankets, so infants sleep 
longer and with fewer disruptions. 
 
There is little evidence evaluating the safety of weighted wearable blankets in infants and the 
risk of sleep-related injury. A number of doctors and safe sleep advocates argue that weighted 
wearable blankets might compress infant chests, making it harder for them to breathe, pump 
blood, and move around. The American Association of Pediatrics (AAP) has speculated the 
addition of weight to an infant’s chest could cause compression, making chest expansion more 
difficult, and reducing respiration. The AAP believes the additional blanket covering the infant 
increases the possibility of overheating, a risk factor for SIDS2-5.  Preliminary data from a small 
sample study commissioned by Nested Bean suggests weighted wearable blankets are associated 
with reductions in oxygen saturation levels in infants at increasing weights, although oxygen 
saturation levels remained within normal ranges at all weights tested. In contrast, in a pilot study 
of infants with Neonatal Abstinence Syndrome (NAS), the use of weighted wearable blankets 
reduced NAS symptoms but did not significantly change infant temperature or breathing rates 
and no adverse events were observed6. The Consumer Product Safety Commission has received 
one report of a fatality due to suffocation associated with the Nested Bean weighted infant sleep 
product, but the infant was also on an infant lounger which can pose a suffocation and 
asphyxiation risk.   
 
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. 
 
An initial pilot safety study will 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. Participants will also be observed for any hindrance in 
their ability to move due to the weighted wearable blanket. A member of the study team will be 
present during the intervention and continuously monitor the infant’s vital signs, allowing for 
immediate evaluation and correction if needed. We plan to expand this study to include an at-
home cohort in the near future (see secondary objective). 
 

IRB# 21638 
Document Date: 20Feb2024 (Initial submission)  
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Objectives 
• 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. 
Outcome Measures/Endpoints 
Endpoints  
Measurement 
Timeframe 
Heart Rate 
EKG 
At start, duration of nap 
Respiratory Rate 
Respiratory effort belts 
At start, duration of nap 
Body Temperature 
Manual recording 
 
(Ear thermometer) 
At start (before wrapping the 
participant in the blanket); at the end of 
the study and during a (feed) break 
(before unwrapping the participant 
from the blanket) 
Oxygen Saturation 
Pulse oximetry 
At start, duration of nap 
Infant Movement 
Observation 
Duration of nap 
Eligibility  
The target population for this study are healthy infants, aged 0-12 months, weighing at least 8 or 
more lbs. Individuals of any sex, race or ethnicity may participate. The study population is 
restricted to this specific age group because the objective is focused on the safety and efficacy of 
weighted wearable blankets on infants. 
Inclusion Criteria 
1. Ability of parent, caregiver or legal guardian/representative to understand a 
written informed consent document and choose to participate in the study. 
2. 0-12 months of age 
3. Weight ≥ 8 lbs 
4. Gestational age ≥ 37 weeks 
5. Health status: healthy infant without underlying cardiac, neurological, or 
pulmonary disorders. 
6. Infant is naive to a weighted wearable blanket. 

IRB# 21638 
Document Date: 20Feb2024 (Initial submission)  
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Exclusion Criteria 
1. Health status: medical diagnosis associated with underlying cardiac, 
neurological, or pulmonary disorder. 
2. Weight < 8 lbs 
3. Gestational age < 37 weeks 
4. Gestational use of marijuana, alcohol, or illicit drugs 
5. Home environment: use of cigarettes, vaping, e-cigarettes, or marijuana 
6. Infant is not naive to a weighted wearable blanket. 
Study Design 
Direct observational pilot study of the safety of weighted wearable blankets on a minimum of 
(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.  
Enrollment/Recruitment 
The target number of total participants is a minimum of 10 infants. The recruitment strategy aims 
to achieve representation of minority groups that reflects the demographics of the population in 
the catchment area. At least 5 infants must be 0-3 months and all others can be any age between 
0 and 12 months of age. 
 
Participants will be recruited in a variety of ways:  
 
Flyers will be posted in the hospital(s) and/or on campus in places frequented by 
potential participants (e.g., elevators, food courts, parking garage elevators) or public 
places such as parks, grocery stores or churches. In addition, we will provide flyers 
and/or brochures to the various maternity wards at Riley, University & Methodist. 
 
Brochures will be available for patients referred to the Sleep Center at Riley or 
established patients at a clinic visit. Patients who are already scheduled for a sleep study, 
and meet eligibility criteria, will be contacted by phone and introduced to the study. If the 
patient is interested, we will send the brochure and the consent (either by USPS or email). 
 
The flyers and brochures will be shared with faculty physicians (in the division of 
Pediatric Pulmonology, Allergy and Sleep Medicine) as well as RN and other staff in the 
Sleep Center and maternity wards (for informational purposes only, they will not consent 
subjects). We might also include the flyer in weekly newsletters and/or internal 
communications. 
 
Social media ads will be placed on Facebook and/or Instagram and clicking on this ad 
will direct potential participants to the study’s web site 

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Document Date: 20Feb2024 (Initial submission)  
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(https://dreamlandbabyco.com/pages/clinical-trial) where they can find phone and email 
information for the study team. 
Study Procedures 
During this study, participants will have one study visit. This visit will take place in the Sleep 
Center at Riley Hospital for Children at IU Health. 
  
• Informed consent – we will explain the study and ask for written consent; participants 
will receive a signed copy of the consent to keep 
o depending on how the participant was recruited, the informed consent discussion 
and written consent may have already occurred virtually 
• Review of inclusion/exclusion criteria 
• Collection of demographic data (infant age, sex, weight) and review of clinical data 
(current medications, other non-pharmacologic interventions, evidence of cardiac, 
neurological, or pulmonary disorders) from participant medical records and parent report 
• Vital signs measurements (heart rate, respiratory rate, body temperature, oxygen 
saturation) will be obtained at baseline and monitored throughout the sleep study 
• Height and weight measurements will be obtained once, at baseline 
• Participants will be placed in weighted wearable blanket such that the blanket does not 
cover the head/face or restrain the infant  
• Participants will then be put to sleep on their backs 
• Vital signs will be monitored over a 6–8-hour period with standard polysomnography 
equipment 
• Upon infant awakening at the end of the nap, the weighted wearable blanket will be 
removed, and vital sign measurements will be repeated  
• One week after the nap polysomnogram, subjects will be contacted by phone to complete 
a short questionnaire 
 
The following stopping parameters will be used for this study. Parameters are noted when the 
infant is quietly sleeping and the changes observed are not due to agitation or crying. Baseline 
data will be recorded before and after placing the infant into the weighted, wearable blanket. 
 
Endpoint 
Stopping Parameters 
Heart rate 
Persistent increase by >20 from baseline for 15 minutes 
Respiratory rate 
Persistent increase by >10 from baseline for 15 minutes 
Body temperature 
Increase by more than 2o from baseline 
Oxygen saturation 
Persistent drop by >10% from baseline 
Infant movement 
Agitation and unable to settle to sleep >15 minutes 
 
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. 

IRB# 21638 
Document Date: 20Feb2024 (Initial submission)  
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Reportable Events 
We will follow the IU HRPP Reportable Events Policy and Guidance, as needed. Severe adverse 
events (SAEs) will be reported to the FDA in accordance with 21 CFR 312.32. 
 
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of 
a drug or device in humans, whether or not considered drug- or device-related. An SAE is 
defined as an adverse event or suspected adverse reaction is considered "serious" if, in the view 
of the investigator, it results in any of the following outcomes: Death, a life-threatening adverse 
event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or 
significant incapacity or substantial disruption of the ability to conduct normal life functions, or a 
congenital anomaly/birth defect. Important medical events that may not result in death, be life-
threatening, or require hospitalization may be considered serious when, based upon appropriate 
medical judgment, they may jeopardize the patient or participant and may require medical or 
surgical intervention to prevent one of the outcomes listed in this definition. Collection of AEs 
and SAEs will begin at the time of consent. 
Loss of confidentiality is always a potential adverse event and will be reported per existing 
Indiana University and Indiana University Health policies.  
Study Withdrawal/Discontinuation 
Participants are free to withdraw from participation in the study at any time for any reason. 
 
The study team may discontinue a participant from the study for any of the following reasons: 
• Unacceptable adverse event(s) 
• Significant study intervention non-compliance 
• The participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation 
Statistical Considerations 
Sample Size Considerations 
 
In the pilot safety study, the total sample size will be a minimum of 10 infants. All 
participants will receive the same intervention. Data from all participants who complete 
both baseline and follow-up assessments will be included in the analysis. 
 
 
Statistical Analysis Plans: 
 
Primary Analysis (Safety) 
Means and standard deviations for each vital sign will be calculated at both baseline and 
during the intervention. Summary statistics based on demographic and baseline 
characteristics will be gathered. A Paired t-test will be performed to compare the means 

IRB# 21638 
Document Date: 20Feb2024 (Initial submission)  
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of each vital sign at baseline and during the intervention. We will also use a linear mixed 
effect model to determine differences in vital signs. 
 
The t-statistic and corresponding p-value will be calculated at a significance level of 0.05 
alpha. If the p-value is less than 0.05, this will be interpreted as a statistically significant 
difference in the vital sign before and after wearing the weighted wearable blanket. If the 
p-value is greater than 0.05, this will be interpreted as no significant difference in the 
vital sign before and after wearing the weighted wearable blanket. 
Reporting and Documentation of Results 
Measures and Instruments 
 
Polysomnography (PSG) Equipment 
PSG will be conducted using a multi-channel PSG system Respironics Alice G3 that is 
designed for sleep studies. The system will include the following components: 
Electroencephalography (EEG) to measure brain activity, Electromyography (EMG) to 
monitor muscle activity, Electrooculography (EOG) to record eye movements, 
Electrocardiography (ECG) for heart rate monitoring, Respiratory effort belts to measure 
chest and abdominal movements, Nasal and oral airflow sensors to monitor airflow, Pulse 
oximetry to measure oxygen saturation levels, and Video recording for behavioral 
monitoring during sleep. Prior to each PSG recording, the equipment will be calibrated 
according to American Academy of Sleep Medicine (AASM) guidelines to ensure 
accurate measurements, and quality control checks will be performed regularly to ensure 
proper functioning of sensors and electrodes during the study. The following 
physiological variables will be continuously measured and recorded during PSG: 
 
• Electroencephalography (EEG): EEG electrodes will be placed according to the 
international 10-20 system to record brain activity and identify sleep stages (e.g., 
wake, NREM, REM). 
• Electromyography (EMG): EMG electrodes will be positioned to monitor muscle 
activity, including chin and limb muscles, to assess muscle tone and movements 
during sleep. 
• Electrooculography (EOG): EOG electrodes will be used to detect eye 
movements, which are important for distinguishing sleep stages and identifying 
rapid eye movement (REM) sleep. 
• Electrocardiography (ECG): ECG electrodes will be placed to monitor heart rate 
and detect any cardiac abnormalities during sleep. 
• Respiratory Parameters: Respiratory effort belts will record chest and abdominal 
movements to assess breathing patterns; Nasal and oral airflow sensors will 
measure airflow and detect apnea and hypopnea events; and Pulse oximetry will 
monitor oxygen saturation levels. 

IRB# 21638 
Document Date: 20Feb2024 (Initial submission)  
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Privacy/Confidentiality  
All study data will be treated as confidential information. Similarly, the participant’s medical 
history will also be treated as confidential with no identifiable information released or shared 
with individuals outside the study team. 
Follow-up and Record Retention 
All study records will be kept in a secured office or locked file cabinet or on a password 
protected computer server at the study site. Only the study investigators and research team will 
have access to the link between the participant information. Information linking a participant’s 
name to a participant identification number will be stored securely. 
Regulatory Compliance 
This study will be carried out in accordance with International Conference on Harmonisation 
Good Clinical Practice (ICH GCP). Study investigators and clinical trial site staff who are 
responsible for the conduct, management, or oversight of clinical trials have completed Human 
Subjects Protection and ICH GCP Training. 
 
The protocol, the proposed informed consent form, recruitment materials, and all subject-facing 
materials will be submitted to the Institutional Review Board (IRB) for review and 
approval.  Approval of both the protocol and the consent form must be obtained before any 
participants are enrolled.  Any amendment to the protocol will require review and approval by 
the IRB before the changes are implemented to the study.  In addition, all changes to the consent 
form will be IRB-approved; a determination will be made regarding whether a new consent 
needs to be obtained from participants who provided consent, using a previously approved 
consent form. 
References 
1. Tham EK, Schneider N, Broekman BF. Infant sleep and its relation with cognition and 
growth: a narrative review. Nat Sci Sleep. 2017 May 15;9:135-149.  
 
 
2. Fleming P, Gilbert R, Azaz Y, et al. Interaction between bedding and sleeping position in 
the sudden infant death syndrome: a population based case-control study. BMJ 
1990;301:85-9 
3. Ponsonby A-L, Dwyer T, Gibbons lE, Cochrane JA, Jones ME, McCall MJ. Thermal 
environment and sudden infant death syndrome: case-control study. BMJ 1992;304:277-
82  
4. Ponsonby A-L, Dwyer T, Gibbons LE, Cochrane JA, Wang Y-G. Factors potentiating the 
risk of sudden infant death syndrome associated with the prone position. N Engl J Med 
1993;329:377-82 
 
 
5. Iyasu S, Randall LL, Welty TK, et al. Risk factors for sudden infant death syndrome 
among northern plains Indians. Jama 2002;288:2717-23 

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6. Summe V, Baker RB, Eichel MM. Safety, Feasibility, and Effectiveness of Weighted 
Blankets in the Care of Infants With Neonatal Abstinence Syndrome: A Crossover 
Randomized Controlled Trial. Adv Neonatal Care 2020;20:384-91