Effectiveness of Chilipad in Enhancing Sleep Quality & Wellbeing

NCT06614530 | Not Yet Recruiting

• 1 other identifier: 13223
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleep; Wellness

Outcome Measures

Primary Outcomes (4)

• Deep Sleep as Measured by Sleep Me Sleep Tracker

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

  Day 30

• REM Sleep as Measured by Sleep Me Sleep Tracker

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

  Day 30

• Time to Sleep as Measured by Sleep Me Sleep Tracker

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

  Day 30

• PROMIS Sleep Disturbance Scale: PROMIS-SD Score

  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.

  30 days

Secondary Outcomes (2)

• 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

Study Arms (1)

Chilipad Docker Pro Interventional Arm

EXPERIMENTAL

Users will receive a Chilipad Docker Pro.

Device: Chilipad Docker Pro

Interventions

Chilipad Docker Pro DEVICE

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.

Chilipad Docker Pro Interventional Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Efforia, Inc: lead

Study Officials

• Matthew M Amsden, MBA

  Efforia, Inc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew M Amsden, MBA

CONTACT

646-679-2479; help@efforia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 26, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-09