SleepEarly Phase 1NCT05463302
Investigating the Efficacy of Sleepgift Blanket on Sleep Quality and Heart Health
A Early Phase 1 study testing Active sleepgift blanket in people with Sleep, run by University of Manitoba at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Active sleepgift blanket
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2023to 11 Oct 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 y<age<70 years
- Being generally healthy (cognitively and psychologically)
- ability to read, write and speak English fluently.
Who cannot join
- Being diagnosed with any neurological, intellectual disability, major depression/anxiety, bipolar disorder, schizophrenia or any other major mood disorder.
- Inability to adequately communicate in English
- Current substance abuse disorder
- Currently participating in another therapeutic study
- Being on a regular pain killer, sleeping or depression pill.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Sleep
- Being tested
- Active sleepgift blanket, Sham Sleepgift Blanket
- Keywords
- electromagnetic field effect, sleep quality, EMF blocker
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active sleepgift blanketDevice
Participants for group1 will be provided with real/active sleepgift blanket first for 10 consecutive nights and then cross over.
Sham Sleepgift BlanketDevice
Participants for group 2 will be provided with sham sleepgift blanket for 10 consecutive nights and then cross over.
| Study group | Role | What they receive |
|---|---|---|
| Active EMF blanket | Active comparator | participants will receive the real EMF blocker blanket Receives: Device: Active sleepgift blanket; Device: Sham Sleepgift Blanket |
| Sham EMF blanket | Placebo comparator | participants will receive the sham EMF blocker blanket Receives: Device: Active sleepgift blanket; Device: Sham Sleepgift Blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality measure
The change in the value of Odds of the Product (ORP) from baseline line to post-intervention, measured by the Prodigy device which is a combination of the EEG band waves. ORP is only one value output of the device.
Measured: Through study completion, 2 years approximately
Secondary outcomes (1)
heart rate variability
the change in heart rate variability (HRV) measured from beat to beat R-R interval.
Measured: Through study completion, 2 years approximately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 Jan 2023
- Primary completion11 Oct 2024
- Study completion11 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- it is two period design with one cross over
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- BB Holistics
- Responsible party
- Sponsor
- Investigators
- Zahra Moussavi, Ph.D., Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463302
- Sponsor's protocol ID
- Sleep Gift Blanket
- Status last verified
- Dec 2023
- First submitted
- 12 Jul 2022
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: When the study is finished, de-identified data could be shared publicly by other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Efficacy of Sleepgift Blanket on Sleep Quality and Heart Health
- ClinicalTrials.gov ID
- NCT05463302
- Acronym / sponsor ID
- Sleep Gift Blanket
- Conditions
- Sleep
- Keywords
- electromagnetic field effect, sleep quality, EMF blocker
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- BB Holistics
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 11 Oct 2024 (actual)
- Study completion
- 11 Oct 2024 (actual)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- it is two period design with one cross over
| Arm | Type | Receives |
|---|---|---|
| Active EMF blanket | Active comparator | Device: Active sleepgift blanket, Device: Sham Sleepgift Blanketparticipants will receive the real EMF blocker blanket |
| Sham EMF blanket | Placebo comparator | Device: Active sleepgift blanket, Device: Sham Sleepgift Blanketparticipants will receive the sham EMF blocker blanket |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 y<age<70 years
- Being generally healthy (cognitively and psychologically)
- ability to read, write and speak English fluently.
Key exclusion criteria (5 listed)
- Being diagnosed with any neurological, intellectual disability, major depression/anxiety, bipolar disorder, schizophrenia or any other major mood disorder.
- Inability to adequately communicate in English
- Current substance abuse disorder
- Currently participating in another therapeutic study
- Being on a regular pain killer, sleeping or depression pill.
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 |
|---|---|---|
| Active sleepgift blanketParticipants for group1 will be provided with real/active sleepgift blanket first for 10 consecutive nights and then cross over. | Device | Active EMF blanket, Sham EMF blanket |
| Sham Sleepgift BlanketParticipants for group 2 will be provided with sham sleepgift blanket for 10 consecutive nights and then cross over. | Device | Active EMF blanket, Sham EMF blanket |
Primary outcome
Sleep quality measure
Time frame: Through study completion, 2 years approximately
The change in the value of Odds of the Product (ORP) from baseline line to post-intervention, measured by the Prodigy device which is a combination of the EEG band waves. ORP is only one value output of the device.
1 secondary outcome
heart rate variability
Time frame: Through study completion, 2 years approximately
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: Yes. When the study is finished, de-identified data could be shared publicly by other researchers.
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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.
Zahra Moussavi, Ph.D. principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Active sleepgift blanket in people with Sleep, run by University of Manitoba at 1 site in Canada.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 3 Apr 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sleep quality measure (time frame: Through study completion, 2 years approximately). 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 3 Apr 2025.