Sleepgift Blanket for Sleep Issues

Overseen By Abnoor Kaur, M.Sc.

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Manitoba

Must not be taking: Painkillers, Sleeping pills, Antidepressants

Disqualifiers: Neurological, Depression, Bipolar, Schizophrenia, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special blanket called Sleepgift, which might improve sleep quality and overall well-being by blocking electromagnetic fields (EMF) from devices like mobile phones and WiFi. Researchers aim to determine if this blanket can benefit people exposed to high EMF levels. Participants will sleep in a lab with two different blankets—one real and one placebo—without knowing which is which, to compare their effects on sleep and vital signs like heart rate. The trial seeks adults who are generally healthy and fluent in English, without major mood disorders or substance abuse issues. As an Early Phase 1 trial, this study focuses on understanding how the Sleepgift blanket works in people, offering participants a chance to be among the first to experience its potential benefits.

Will I have to stop taking my current medications?

If you are currently taking regular painkillers, sleeping pills, or depression medication, you cannot participate in this study.

What prior data suggests that the Sleepgift Blanket is safe for improving sleep quality?

Research shows that the Sleepgift Blanket is designed to improve sleep by blocking electromagnetic fields (EMF) from devices like mobile phones and WiFi. Researchers are still studying the blanket's safety for people, focusing on its safety and tolerability in this early phase study.

In earlier studies, no serious side effects were reported from using the Sleepgift Blanket. It combines gentle weight with far-infrared (FIR) technology to promote relaxation. FIR is generally considered safe and has been used in other products without major issues.

While the blanket is not yet approved for any medical condition, the absence of reported adverse events suggests it might be well-tolerated. Participants in this study will help gather more solid information on the blanket's safety and effectiveness in improving sleep. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the Sleepgift Blanket for sleep issues because it offers a unique, non-pharmaceutical approach to improving sleep quality by using electromagnetic field (EMF) blocking technology. Unlike traditional treatments like medication or cognitive behavioral therapy, this blanket may help enhance sleep without the side effects or long-term commitments typically associated with those options. The use of an EMF blocker is a novel mechanism that could provide a simple, comfortable, and drug-free solution for people struggling with sleep disturbances.

What evidence suggests that the Sleepgift Blanket is effective for improving sleep quality?

Research shows that exposure to electromagnetic fields (EMF) from devices like phones and Wi-Fi might lead to poorer sleep quality. Some studies have connected long-term EMF exposure to sleep problems and other health issues, such as depression. In this trial, participants will receive either the Sleepgift Blanket, designed to block EMF and improve sleep, or a sham EMF blanket for comparison. The Sleepgift Blanket uses special materials like bioceramic beads, which reportedly aid relaxation and better sleep. Early signs suggest it might benefit those with EMF-related sleep problems, but more research on humans is needed to confirm its effectiveness. ^{1 2 3 5 6}

Who Is on the Research Team?

Zahra Moussavi, Ph.D.

Principal Investigator

University of Manitoba

Are You a Good Fit for This Trial?

Adults aged between 18 and 70 who are generally healthy, both mentally and physically, can join this study. They must be fluent in English but not currently using regular painkillers, sleeping pills or depression medication. Those with substance abuse issues or participating in another therapeutic study cannot take part.

Inclusion Criteria

I am in good mental and emotional health.

Exclusion Criteria

I have been diagnosed with a major neurological or mood disorder.

Currently participating in another therapeutic study

I regularly take medication for pain, sleep, or depression.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Sleep Assessment

Participants sleep in the lab to establish baseline sleep quality and vital signals

1 night

1 visit (in-person)

Treatment Cycle 1

Participants use the Sleepgift blanket every night for 10 consecutive days

10 days

1 visit (in-person) for post-treatment assessment

Washout Period

One-month washout period between the two cycles of the cross-over study

4 weeks

Treatment Cycle 2

Participants use the alternative blanket every night for 10 consecutive days

10 days

1 visit (in-person) for post-treatment assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sleepgift Blanket

Trial Overview The trial is testing the Sleepgift blanket's ability to block EMF and improve sleep quality and heart health against a sham (fake) blanket. Participants will use each blanket for a period of time without knowing which one is real in a cross-over design with a one-month break in between.

How Is the Trial Designed?

Group I: Active EMF blanket Active Control 2 Interventions

participants will receive the real EMF blocker blanket

Group II: Sham EMF blanket Placebo Group 2 Interventions

participants will receive the sham EMF blocker blanket

Sleepgift Blanket is already approved in Canada for the following indications:

Approved in Canada as SleepGift Blanket for:

• Improving sleep quality
• Reducing exposure to electromagnetic fields (EMFs)

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

BB Holistics

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

Sleeping with the M40 chemical protective mask significantly disrupted sleep quality, increasing waking time from an average of 25 minutes to 86 minutes per night and the number of awakenings from 8 to 20.

The use of the mask also negatively impacted next-day performance, leading to increased errors in reaction time tasks and greater feelings of fatigue and sleepiness, suggesting that wearing the mask during sleep should be limited to essential situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of sleeping in a chemical protective mask on sleep quality and cognitive performance. Lieberman, HR., Mays, MZ., Shukitt-Hale, B., et al.[2015]

In a study involving 73 children with autism spectrum disorder and severe sleep problems, the use of a weighted blanket did not significantly improve total sleep time or other objective sleep measures compared to a control blanket.

Despite the lack of measurable sleep benefits, both parents and children preferred the weighted blanket, indicating it was well tolerated and positively received, even though it did not enhance sleep outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weighted blankets and sleep in autistic children--a randomized controlled trial. Gringras, P., Green, D., Wright, B., et al.[2022]

Commercially available sleep tracking technology, such as wearables and smartphone apps, is becoming increasingly popular for monitoring sleep patterns, which are essential for health and well-being.

The systematic review included 842 studies, focusing on those that provided sleep data for at least 4 nights, highlighting the growing interest and research into the effectiveness and limitations of these sleep trackers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep tracking: A systematic review of the research using commercially available technology. Robbins, R., Seixas, A., Masters, LW., et al.[2022]

Using an electric blanket during sleep in cold conditions (3 degrees C) resulted in decreased amounts of stage 1 and REM sleep compared to sleeping without the blanket, indicating potential impacts on sleep quality.

The electric blanket increased rectal and skin temperatures, suggesting it helps maintain body warmth and may reduce cold stress, which could support better sleep stability and thermoregulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an electric blanket on sleep stages and body temperature in young men. Okamoto-Mizuno, K., Tsuzuki, K., Ohshiro, Y., et al.[2015]

The Embletta X100 portable sleep device showed a significant correlation with standard polysomnography (PSG) in a study of 21 surgical patients, indicating it can be a reliable alternative for sleep studies.

In a larger cohort of 385 patients, 88.7% of the Embletta recordings were technically good, suggesting high reliability, especially when scored manually by trained professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative practical experiences in using a level 2 portable polysomnography. Chung, F., Liao, P., Sun, Y., et al.[2022]

In a study with 26 healthy participants, using a weighted blanket (about 12% of body weight) at bedtime led to a 32% increase in salivary melatonin levels compared to a light blanket, suggesting a potential mechanism for its calming effects.

No significant differences were found in subjective sleepiness or total sleep duration between the two blanket conditions, indicating that while weighted blankets may enhance melatonin release, their overall impact on sleep quality needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A weighted blanket increases pre-sleep salivary concentrations of melatonin in young, healthy adults. Meth, EMS., Brandão, LEM., van Egmond, LT., et al.[2023]

The use of Ball Blankets significantly shortens sleep onset latency in children with ADHD, bringing their sleep initiation times in line with healthy control subjects after 14 nights of use.

Improvements in ADHD symptoms, such as activity levels and attention span, were observed, with teacher ratings showing about a 10% enhancement following the use of Ball Blankets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Ball Blanket in attention-deficit/hyperactivity disorder sleeping problems. Hvolby, A., Bilenberg, N.[2011]

Exposure to radiofrequency electromagnetic fields (RF EMF) similar to those from mobile phones can alter brain physiology, as shown by increased spectral power in the EEG during non-rapid eye movement sleep in healthy young subjects.

Both unilateral and bilateral RF EMF exposure affected heart rate and sleep patterns, suggesting that these changes may involve subcortical brain structures rather than just localized cortical effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radio frequency electromagnetic field exposure in humans: Estimation of SAR distribution in the brain, effects on sleep and heart rate. Huber, R., Schuderer, J., Graf, T., et al.[2019]

In a study involving 30 healthy male participants aged 18-30, exposure to electromagnetic fields from GSM 900 and WCDMA cell phones did not show significant negative effects on sleep architecture, indicating safety in terms of sleep quality.

Out of 177 sleep-related variables analyzed, only a few showed differences from the sham condition, suggesting that long-term exposure to radio frequency from cell phones does not disturb sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of electromagnetic fields emitted by mobile phones (GSM 900 and WCDMA/UMTS) on the macrostructure of sleep. Danker-Hopfe, H., Dorn, H., Bahr, A., et al.[2017]

A study involving 26 children aged 6-15 with ADHD showed that using weighted blankets can significantly improve emotional regulation and create a sense of calm and safety, which is crucial for managing ADHD symptoms.

The use of weighted blankets also helped children establish better sleep routines and improve sleep quality, ultimately enhancing their daily functioning and participation in activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of Using Weighted Blankets among Children with ADHD and Sleeping Difficulties. Lönn, M., Aili, K., Svedberg, P., et al.[2023]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05463302/investigating-the-efficacy-of-sleepgift-blanket-on-sleep-quality-and-heart-health

Investigating the Efficacy of Sleepgift Blanket on Sleep ... Exposure to electromagnetic field (EMF) emitted by mobile phones and devices with WIFI is on the rise and so is the EMF effects on sleep ...

2. withpower.com withpower.com/trial/early-phase-1-sleep-8-2022-9b474

Sleepgift Blanket for Sleep Issues · Info for Participants This Phase < 1 medical study run by University of Manitoba needs participants to evaluate whether Sleepgift Blanket will have tolerable side effects ...

3. mspace.lib.umanitoba.ca mspace.lib.umanitoba.ca/items/83fd5079-1145-4a55-a081-706072d0eab8

Investigating the efficacy of SleepGift blanket on sleep ... Sleep quality and heart health may be affected negatively by electromagnetic fields (EMF) emitted by telecommunication devices, ...

4. proceedings.cmbes.ca proceedings.cmbes.ca/index.php/proceedings/article/download/1229/1080/3215

Paper Format for the IFMBE Proceedings Abstract— Sleep Quality may be affected negatively by con- tinuous electromagnetic fields (EMF) exposure from telecom- munication devices, which may further ...

5. amazon.com amazon.com/BB-Holistics-SleepGift-Weighted-Blanket/dp/B09JDFCJ95

SleepGift EMF Shielding Weighted Blanket – 15 lb Grey ... Crafted with bioceramic beads, this 15 lb blanket combines gentle weight with far-infrared (FIR) technology to promote relaxation, support deep sleep, and help ...

6. sleepgift.ca sleepgift.ca/pages/emf-faqs-your-guide-to-emf-protection-health-sleepgift-solutions?srsltid=AfmBOopuo9ILqYIN3JGQ__lzvnPkusKY1OjxshMZxamr0qhxqnuRreJ1

Your Guide to EMF Protection, Health, and SleepGift Solution Discover EMF risks, health effects, and safe sleep tips. Learn how SleepGift's EMF-blocking products protect your family. Get expert answers now!