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Not yet recruiting NCT06614530

Effectiveness of Chilipad in Enhancing Sleep Quality & Wellbeing

No phase Interventional Sleep Wellness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chilipad Docker Pro.
Who it may be relevant to
Registry conditions: Sleep, Wellness. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Device Chilipad Docker Pro
    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 factor

Primary outcome measures

  • Deep Sleep as Measured by Sleep Me Sleep Tracker [Time frame: Day 30]
  • REM Sleep as Measured by Sleep Me Sleep Tracker [Time frame: Day 30]
  • Time to Sleep as Measured by Sleep Me Sleep Tracker [Time frame: Day 30]
  • PROMIS Sleep Disturbance Scale: PROMIS-SD Score [Time frame: 30 days]
Secondary outcome measures (2)
  • Wellbeing Survey: Wellbeing Survey Score [Time frame: 30 Day]
  • 36-Item Short Form Survey Instrument (SF-36): 36-Item Short Form Survey Instrument (SF-36) Score [Time frame: 30 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06614530 · 13223

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗