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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-10-11

Brief Summary

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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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Detailed Description

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Conditions

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Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

it is two period design with one cross over

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

participants receive two similar blankets, while one of them is real and one is sham but they are blind to which one is which.

Study Groups

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Active EMF blanket

participants will receive the real EMF blocker blanket

Group Type ACTIVE_COMPARATOR

Active sleepgift blanket

Intervention Type DEVICE

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

Sham Sleepgift Blanket

Intervention Type DEVICE

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

Sham EMF blanket

participants will receive the sham EMF blocker blanket

Group Type PLACEBO_COMPARATOR

Active sleepgift blanket

Intervention Type DEVICE

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

Sham Sleepgift Blanket

Intervention Type DEVICE

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

Interventions

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Active sleepgift blanket

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

Intervention Type DEVICE

Sham Sleepgift Blanket

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes