Clinical trial NCT06614530: Effectiveness of Chilipad in Enhancing Sleep Quality &amp;amp; Wellbeing
Official title: Effectiveness of Chilipad in Enhancing Sleep Quality &amp;amp; Wellbeing
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sleep
Wellness
Lead sponsor: Efforia, Inc
Sponsor class: INDUSTRY
First posted: 2024-09-26
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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\&amp;#39;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\&#39;s effectiveness.

Eligibility criteria: 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.

Primary outcomes:
measure: Deep Sleep as Measured by Sleep Me Sleep Tracker
timeFrame: Day 30
measure: REM Sleep as Measured by Sleep Me Sleep Tracker
timeFrame: Day 30
measure: Time to Sleep as Measured by Sleep Me Sleep Tracker
timeFrame: Day 30
measure: PROMIS Sleep Disturbance Scale: PROMIS-SD Score
timeFrame: 30 days
Secondary outcomes:
measure: Wellbeing Survey: Wellbeing Survey Score
timeFrame: 30 Day
measure: 36-Item Short Form Survey Instrument (SF-36): 36-Item Short Form Survey Instrument (SF-36) Score
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Efforia, Inc
name: Matthew M Amsden, MBA
role: PRINCIPAL_INVESTIGATOR
References: