Investigating the Efficacy of Sleepgift Blanket on Sleep Quality and Heart Health

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 Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Device: Active sleepgift blanket; Device: Sham Sleepgift Blanket

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3L 2P4
      • Riverview Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 y<age<70 years
• Being generally healthy (cognitively and psychologically)
• ability to read, write and speak English fluently.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active EMF blanket; participants will receive the real EMF blocker blanket	Device: Active sleepgift blanket; Participants for group1 will be provided with real/active sleepgift blanket first for 10 consecutive nights and then cross over.; Device: Sham Sleepgift Blanket; Participants for group 2 will be provided with sham sleepgift blanket for 10 consecutive nights and then cross over.
Placebo Comparator: Sham EMF blanket; participants will receive the sham EMF blocker blanket	Device: Active sleepgift blanket; Participants for group1 will be provided with real/active sleepgift blanket first for 10 consecutive nights and then cross over.; Device: Sham Sleepgift Blanket; Participants for group 2 will be provided with sham sleepgift blanket for 10 consecutive nights and then cross over.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through study completion, 2 years approximately

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart rate variability	the change in heart rate variability (HRV) measured from beat to beat R-R interval.	Through study completion, 2 years approximately

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: BB Holistics
• Investigators: Principal Investigator: Zahra Moussavi, Ph.D., University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): October 11, 2024
• Study Completion (Actual): October 11, 2024

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: sleep quality; electromagnetic field effect; EMF blocker
• Other Study ID Numbers: Sleep Gift Blanket

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: When the study is finished, de-identified data could be shared publicly by other researchers.
• IPD Sharing Time Frame: After Aug. 2025
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No