An Early Phase 1 interventional study of Active sleepgift blanket and Sham Sleepgift Blanket in Sleep, sponsored by University of Manitoba. Completed at 1 site in Canada. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-03.
Sponsored by University of Manitoba · Early Phase 1, Interventional, and Treatment
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.
University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
participants will receive the real EMF blocker blanket
Device: Active sleepgift blanket · Device: Sham Sleepgift Blanket
participants will receive the sham EMF blocker blanket
Device: Active sleepgift blanket · Device: Sham Sleepgift Blanket
Participants for group1 will be provided with real/active sleepgift blanket first for 10 consecutive nights and then cross over.
Participants for group 2 will be provided with sham sleepgift blanket for 10 consecutive nights and then cross over.
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.
Time frame: Through study completion, 2 years approximately
heart rate variability
the change in heart rate variability (HRV) measured from beat to beat R-R interval.
Time frame: Through study completion, 2 years approximately
Plan to share: Yes — When the study is finished, de-identified data could be shared publicly by other researchers.
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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University of Manitoba