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

U

University of Manitoba

Status and phase

Enrolling
Early Phase 1

Conditions

Sleep

Treatments

Device: Sham Sleepgift Blanket
Device: Active sleepgift blanket

Study type

Interventional

Funder types

Other

Identifiers

NCT05463302
Sleep Gift Blanket

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

30 participants in 2 patient groups, including a placebo group

Active EMF blanket
Active Comparator group
Description:
participants will receive the real EMF blocker blanket
Treatment:
Device: Active sleepgift blanket
Device: Sham Sleepgift Blanket
Sham EMF blanket
Placebo Comparator group
Description:
participants will receive the sham EMF blocker blanket
Treatment:
Device: Active sleepgift blanket
Device: Sham Sleepgift Blanket

Trial contacts and locations

1

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Central trial contact

Abnoor Kaur, M.Sc.; Zahra Moussavi, Ph.D.

Data sourced from clinicaltrials.gov

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