Clinical trial NCT05463302: Investigating the Efficacy of Sleepgift Blanket on Sleep Quality and Heart Health
Official title: Investigating the Efficacy of Sleepgift Blanket on Sleep Quality and Heart Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Sleep
Keywords: electromagnetic field effect
sleep quality
EMF blocker
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: BB Holistics
First posted: 2022-07-18
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: it is two period design with one cross over
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sleep quality measure
timeFrame: Through study completion, 2 years approximately
Secondary outcomes:
measure: heart rate variability
timeFrame: Through study completion, 2 years approximately
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Riverview Health Center
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Zahra Moussavi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: