Chilipad Sleep Optimization Study

NCT07281963 | Recruiting FDA Device

• 1 other identifier: 13228
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the Chilipad Dock Pro Bed Cooling System and Sleep Tracker, examining how bed temperature influences sleep quality and overall well-being.

Conditions

Sleep

Outcome Measures

Primary Outcomes (3)

• PROMIS Sleep Disturbance Scale

  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.

  Change from baseline (Day 1-3) in PROMIS Sleep Disturbance Scale at 4 weeks after the start of the intervention (Day 27-33)

• Well-being Survey

  Please answer the following questions to assess your well-being.

  Change from baseline (Day 1-3) in Well-being Survey at 4 weeks after the start of the intervention (Day 27-33)

• 36-Item Short Form Survey Instrument (SF-36)

  The SF-36, or Short Form 36, is a widely used health-related quality of life questionnaire that consists of 36 questions designed to assess a person's physical and mental well-being. It measures various aspects of an individual's health, including physical functioning, role limitations due to physical and emotional problems, social functioning, mental health, energy and vitality, pain, and general health perceptions. The SF-36 provides a comprehensive overview of a person's health status and is frequently used in clinical research, healthcare assessments, and population health studies. Its versatility and ability to assess multiple dimensions of health make it a valuable tool for evaluating the impact of medical interventions and health-related interventions.

  Change from baseline (Day 1) in SF-36 at 4 weeks after the start of the intervention (Day 29-31)

Study Arms (1)

Single arm where participants act as their own control

EXPERIMENTAL

Single arm where participants act as their own control

Device: Chilipad Dock Pro Bed Cooling System and Sleep Tracker

Interventions

Chilipad Dock Pro Bed Cooling System and Sleep Tracker DEVICE

The Chilipad Dock Pro Bundle is an advanced sleep system designed to optimize sleep by dynamically adjusting the bed's surface temperature. It consists of a thermoregulated mattress pad and a Dock Pro control unit that actively 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 only enhanced when paired with the optional Sleepme Tracker, creating a personalized sleep experience.

Single arm where participants act as their own control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Can read and understand English.
• US resident.
• Willing and able to follow the requirements of the protocol.

You may not qualify if:

• Individuals with concerns about water leakage.
• Individuals with sleep disorders related to changes in temperature
• Individuals with thermal sensitivity
• Individuals who are easily frustrated by technology.
• Individuals with pacemakers or medical implants sensitive to electromagnetic fields
• Pregnant individuals

Sponsors & Collaborators

• Efforia, Inc: lead

Study Sites (1)

Efforia

New York, New York, 10003, United States

RECRUITING

Related Links

• Additional information and join instructions on Efforia

Central Study Contacts

Matthew Amsden

CONTACT

646-679-2479; help@efforia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Arm observational where participants act as their own control

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 15, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): September 25, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

US (1)