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临床试验/NCT06614530
NCT06614530尚未招募不适用

Effectiveness of Chilipad in Enhancing Sleep Quality & Wellbeing

Efforia, Inc0 个研究点目标入组 120 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
主要终点
Deep Sleep as Measured by Sleep Me Sleep Tracker

研究概览

简要总结

This study tests the Chilipad Dock Pro Bed Cooling System and Sleep Tracker, focusing on how temperature affects sleep quality and well-being. Over a 35-day period, metrics captured by our Sleep Tracker and participant feedback will be used to evaluate sleep quality and assess well-being. Participation requires minimal time and effort - set-up, sleep, and check-in periodically to provide feedback.

详细描述

Sleep quality is a cornerstone of well-being, yet many struggle to achieve restful nights. Emerging research suggests that temperature regulation can play a vital role in sleep quality. The Chilipad Dock Pro Bed Cooling System promises to optimize sleep by maintaining an ideal temperature. Social media buzz and user testimonials have lauded its effectiveness, but scientific validation is limited.

The Chilipad Dock Pro is an advanced sleep system designed to optimize sleep by dynamically adjusting the bed's surface temperature. It consists of a mesh mattress pad and a Dock Pro control unit that circulates water through the pad, allowing users to customize the temperature between 55°F and 115°F. The system offers both single and dual control, making it ideal for individual or shared use. Equipped with AI-driven features, the Dock Pro can monitor sleep patterns and environmental factors to make real-time adjustments, ensuring optimal sleep conditions throughout the night. This intelligent temperature management system is enhanced when paired with the optional Sleepme Tracker, creating a personalized sleep experience.

This single-arm trial evaluates the impact of the ChiliPad Dock Pro Bed Cooling System on sleep quality and well-being. Participants act as their control, as placebos are impractical. Participants will be asked to sequentially add Chilipad functionality throughout the trial. The study will use validated scales like the PROMIS Sleep Disturbance Scale, Well-being Survey, and SF-36 to quantify the system's effectiveness.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • in the United States
  • recent purchaser or customer of Sleep.me

排除标准

  • Individuals with severe insomnia
  • Individuals with severe allergies or skin conditions
  • Individuals with pacemakers or implanted medical devices
  • Individuals with severe anxiety or stress disorders
  • Pregnant individuals
  • Individuals who travel across timezones frequently and/or sleep in their own bed less than 21 days in a month.
  • Individuals with incontinence issues
  • Individuals with severe mobility issues.

结局指标

主要结局

Deep Sleep as Measured by Sleep Me Sleep Tracker

时间窗: Day 30

A non-wearable sleep tracker that is placed under the mattress at heart level and automatically tracks sleep information.

REM Sleep as Measured by Sleep Me Sleep Tracker

时间窗: Day 30

A non-wearable sleep tracker that is placed under the mattress at heart level and automatically tracks sleep information.

Time to Sleep as Measured by Sleep Me Sleep Tracker

时间窗: Day 30

A non-wearable sleep tracker that is placed under the mattress at heart level and automatically tracks sleep information.

PROMIS Sleep Disturbance Scale: PROMIS-SD Score

时间窗: 30 days

The PROMIS Sleep Disturbance Scale is a validated and widely used assessment tool developed as part of the Patient-Reported Outcomes Measurement Information System (PROMIS) initiative. It is designed to measure the severity of sleep disturbances and disruptions experienced by individuals. This scale includes a range of questions that assess the frequency and impact of various sleep-related issues, such as difficulty falling asleep, nighttime awakenings, and restless sleep. Healthcare professionals and researchers rely on this scale to better understand and quantify sleep problems in patients, enabling them to tailor interventions and treatment strategies to address sleep-related concerns effectively.

次要结局

  • Wellbeing Survey: Wellbeing Survey Score(30 Day)
  • 36-Item Short Form Survey Instrument (SF-36): 36-Item Short Form Survey Instrument (SF-36) Score(30 days)

研究者

发起方
Efforia, Inc
申办方类型
Industry
责任方
Sponsor

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