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

NCT05463302 | Completed Early Phase 1

• 1 other identifier: Sleep Gift Blanket
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep

Keywords

electromagnetic field effect; sleep quality; EMF blocker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• heart rate variability

  Through study completion, 2 years approximately

Study Arms (2)

Active EMF blanket

ACTIVE COMPARATOR

participants will receive the real EMF blocker blanket

Device: Active sleepgift blanket; Device: Sham Sleepgift Blanket

Sham EMF blanket

PLACEBO COMPARATOR

participants will receive the sham EMF blocker blanket

Device: Active sleepgift blanket; Device: Sham Sleepgift Blanket

Interventions

Active sleepgift blanket DEVICE

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

Active EMF blanket; Sham EMF blanket

Sham Sleepgift Blanket DEVICE

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

Active EMF blanket; Sham EMF blanket

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead
• BB Holistics: collaborator

Study Sites (1)

Riverview Health Center

Winnipeg, Manitoba, R3L 2P4, Canada

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Zahra Moussavi, Ph.D.

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants receive two similar blankets, while one of them is real and one is sham but they are blind to which one is which.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: it is two period design with one cross over

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 18, 2022
• Study Start: January 1, 2023
• Primary Completion: October 11, 2024
• Study Completion: October 11, 2024
• Last Updated: April 3, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After Aug. 2025

Locations

CA (1)