SleepNCT06422364
Assessment of the Safety and Efficacy of Weighted Wearable Blankets in Healthy Infants During Sleep
A study testing Weighted Wearable Blanket provided by Dreamland Baby Co. in people with Sleep, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Weighted Wearable Blanket provided by Dreamland Baby Co.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 22 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, 46202
About this study
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.
Read the 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
- Sleep
- Being tested
- Weighted Wearable Blanket provided by Dreamland Baby Co.
- Keywords
- Sleep, Healthy, Infant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weighted Wearable Blanket provided by Dreamland Baby Co.Device
All infants will be placed in a weighted wearable blanket, provided by Dreamland Baby Co., and complete a nap polysomnogram.
Weighted Wearable Blanket provided by Dreamland Baby Co.Device
All infants will be placed in a weighted wearable blanket, provided by Dreamland Baby Co., and complete an overnight polysomnogram.
| Study group | Role | What they receive |
|---|---|---|
| Nap Polysomnogram | Experimental | 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. Receives: Device: Weighted Wearable Blanket provided by Dreamland Baby Co. |
| Overnight Polysomnogram | Experimental | 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. Receives: Device: Weighted Wearable Blanket provided by Dreamland Baby Co. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Heart Rate
Measured by EKG
Measured: Day 1, during polysomnogram, up to 8 hours
Average Respiratory Rate
Measured by Respiratory effort belts
Measured: Day 1, during polysomnogram, up to 8 hours
Average Body Temperature
Manually measured by ear thermometer
Measured: Day 1, during polysomnogram, up to 8 hours
Average Oxygen Saturation
Measured by pulse oximetry
Measured: Day 1, during polysomnogram, up to 8 hours
Number of Infants With Observed Head Movement
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.
Measured: Day 1, during polysomnogram, up to 8 hours
Number of Infants With Observed Arm Movement
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.
Measured: Day 1, during polysomnogram, up to 8 hours
Number of Infants With Observed Body Movement
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.
Measured: Day 1, during polysomnogram, up to 8 hours
Secondary outcomes (1)
Efficacy of Weighted Wearable Blankets on Sleep Patterns in Healthy Infants During Overnight Sleep
The study was closed before any overnight studies were completed; therefore, no data for this objective was collected.
Measured: Day 1, during polysomnogram, up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 Apr 2024
- Primary completion22 May 2024
- Study completion22 May 2024
Why it stopped: External to study controversy has arisen around safety of the product. Due to concerns raised by USCPSC and the AAP, the PI has terminated site participation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Dreamland Baby Co.
- Responsible party
- Principal investigator, Harish Rao, Indiana University
- Investigators
- Harish Rao, MD, Principal investigator, Riley Hospital for Children at Indiana University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422364
- Sponsor's protocol ID
- 21638
- Status last verified
- Jun 2025
- First submitted
- 26 Apr 2024
- Last updated
- 24 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Safety and Efficacy of Weighted Wearable Blankets in Healthy Infants During Sleep
- ClinicalTrials.gov ID
- NCT06422364
- Acronym / sponsor ID
- 21638
- Conditions
- Sleep
- Keywords
- Sleep, Healthy, Infant
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: External to study controversy has arisen around safety of the product. Due to concerns raised by USCPSC and the AAP, the PI has terminated site participation.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Dreamland Baby Co.
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 21 May 2024 (actual)
- Results
- Posted 24 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nap Polysomnogram | Experimental | Device: Weighted Wearable Blanket provided by Dreamland Baby Co.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 | Experimental | Device: Weighted Wearable Blanket provided by Dreamland Baby Co.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. |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weighted 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. | Device | Nap Polysomnogram |
| Weighted Wearable Blanket provided by Dreamland Baby Co.All infants will be placed in a weighted wearable blanket, provided by Dreamland Baby Co., and complete an overnight polysomnogram. | Device | Overnight Polysomnogram |
Primary outcome
Average Heart Rate
Time frame: Day 1, during polysomnogram, up to 8 hours
Measured by EKG
Average Respiratory Rate
Time frame: Day 1, during polysomnogram, up to 8 hours
Measured by Respiratory effort belts
Average Body Temperature
Time frame: Day 1, during polysomnogram, up to 8 hours
Manually measured by ear thermometer
Average Oxygen Saturation
Time frame: Day 1, during polysomnogram, up to 8 hours
Measured by pulse oximetry
Number of Infants With Observed Head Movement
Time frame: 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
Time frame: 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 Body Movement
Time frame: 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.
1 secondary outcome
Efficacy of Weighted Wearable Blankets on Sleep Patterns in Healthy Infants During Overnight Sleep
Time frame: Day 1, during polysomnogram, up to 12 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Sleep
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harish Rao, MD principal investigator
Riley Hospital for Children at Indiana University Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weighted Wearable Blanket provided by Dreamland Baby Co. in people with Sleep, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Heart Rate (time frame: Day 1, during polysomnogram, up to 8 hours). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.