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OpenTrials
Completed

NCT Number: NCT05463302

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Riverview Health Center

Winnipeg, Manitoba, R3L 2P4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active sleepgift blanket

Device

Participants for group1 will be provided with real/active sleepgift blanket first for 10 consecutive nights and then cross over.

Sham Sleepgift Blanket

Device

Participants for group 2 will be provided with sham sleepgift blanket for 10 consecutive nights and then cross over.

Primary outcomes

  1. 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.

Secondary outcomes

  1. heart rate variability

    Time frame: Through study completion, 2 years approximately

    the change in heart rate variability (HRV) measured from beat to beat R-R interval.

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • BB Holistics

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2022
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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