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

31 Participants Needed

Trial Summary

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 data supports the effectiveness of the Sleepgift Blanket treatment for sleep issues?

Research on similar treatments, like weighted blankets, shows they can help improve sleep in children with conditions like ADHD and autism by providing a calming effect. ^{1 2 3 4 5}

How does the Sleepgift Blanket treatment differ from other treatments for sleep issues?

The Sleepgift Blanket is unique because it offers electromagnetic field (EMF) protection, which is not a feature of typical sleep aids like weighted blankets or electric blankets. This EMF shielding may help reduce potential disruptions to sleep caused by exposure to electromagnetic fields, a factor not addressed by other common sleep treatments. ^{6 7 8 9 10}

What is the purpose of this trial?

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 quality and well-being of individuals with high exposures to EMF. Some studies have shown poor sleep quality among individuals with long-term occupational exposure to EMF, and some have shown association between EMF long-term exposure and neuropsychiatric disorders including depression. This study aims to investigate a commercially available EMF- blocker blanket, called Sleepgift, that claims helping people to have a better sleep and improved health. We will investigate the Sleepgift efficacy on adults' quality of sleep and their vital signals as a measure of their well-being in a placebo-controlled single- blind cross-over designed study. Participants will sleep in our sleep lab at baseline and then 10 days later with the Sleepgift blanket after using it every night for the past 10 consecutive days. Participants will be given two blankets for each cycle of the study as it is a cross-over designed study: one Sleepgift and one regular blanket; they will not know which one is real or sham. There will be one-month washout period between the two cycles of the cross-over study. We aim to enroll 30 adults for the study. Participants' sleep quality will be measured by the established device called Prodogy; their vital signals will also be measured and monitored through the night. The collected data will be analyzed statistically for any significant effect of the Sleepgift blanket on sleep quality and vital signals such as heart's rhythm and heart rate variability.

Research Team

Zahra Moussavi, Ph.D.

Principal Investigator

University of Manitoba

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Use of Ball Blanket in attention-deficit/hyperactivity disorder sleeping problems. [2011]

2. United States pubmed.ncbi.nlm.nih.gov

Weighted blankets and sleep in autistic children--a randomized controlled trial. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Sleep tracking: A systematic review of the research using commercially available technology. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Perioperative practical experiences in using a level 2 portable polysomnography. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Experiences of Using Weighted Blankets among Children with ADHD and Sleeping Difficulties. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Effects of an electric blanket on sleep stages and body temperature in young men. [2015]

7. England pubmed.ncbi.nlm.nih.gov

A weighted blanket increases pre-sleep salivary concentrations of melatonin in young, healthy adults. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of sleeping in a chemical protective mask on sleep quality and cognitive performance. [2015]

9. United States 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. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Effects of electromagnetic fields emitted by mobile phones (GSM 900 and WCDMA/UMTS) on the macrostructure of sleep. [2017]