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

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05463302
• Other study ID #: Sleep Gift Blanket
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 1, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: December 2023
• Source: University of Manitoba
• Contact: Zahra Moussavi, Ph.D.
• Phone: 2044747023
• Email: Zahra.Moussavi[@]umanitoba.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sleep

Intervention

Device:
• Active sleepgift blanket
Participants for group1 will be provided with real/active sleepgift blanket first for 10 consecutive nights and then cross over.
• Sham Sleepgift Blanket
Participants for group 2 will be provided with sham sleepgift blanket for 10 consecutive nights and then cross over.

Locations

Country	Name	City	State
Canada	Riverview Health Center	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	BB Holistics

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	heart rate variability	the change in heart rate variability (HRV) measured from beat to beat R-R interval.	Through study completion, 2 years approximately