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临床试验/NCT05463302
NCT05463302已完成早期 1 期

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

University of Manitoba2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
31
试验地点
2
主要终点
Sleep quality measure

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

盲法说明

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Sleep quality measure

时间窗: Through study completion, 2 years approximately

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.

次要结局

  • heart rate variability(Through study completion, 2 years approximately)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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