Effectiveness of Chilipad in Enhancing Sleep Quality & Wellbeing
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
- Primary Endpoint
- Deep Sleep as Measured by Sleep Me Sleep Tracker
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •in the United States
- •recent purchaser or customer of Sleep.me
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Deep Sleep as Measured by Sleep Me Sleep Tracker
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)