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Chilipad Dock Pro Bed Cooling System for Sleep Quality Enhancement

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What is being tested

Chilipad Docker Pro

Device
Who is being recruted

Over 21 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: October 2024
See protocol details

Summary

Principal SponsorEfforia, Inc
Study ContactMatthew M Amsden, MBA
Last updated: December 13, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2024Actual date on which the first participant was enrolled.

This study focuses on improving sleep quality and well-being through the use of the Chilipad Dock Pro Bed Cooling System. Many people have trouble sleeping well, and research suggests that controlling bed temperature might help. The Chilipad aims to keep the bed at an ideal temperature, which could help users sleep better. Although people on social media have praised the product, this study seeks to provide scientific proof of its effectiveness. The study is important as better sleep quality can significantly enhance overall well-being, addressing an unmet need for many who suffer from poor sleep. Participants in the study will use the Chilipad Dock Pro, which adjusts the bed's temperature through a special mattress pad and control unit. The system allows users to set their preferred temperature, ranging from 55°F to 115°F, and can even adapt in real-time based on sleep patterns. Throughout the trial, participants will gradually incorporate the Chilipad’s features. To measure the results, the study will use scales like the PROMIS Sleep Disturbance Scale and the Well-being Survey. These tools will help determine how effectively the Chilipad improves sleep and overall well-being. The study does not use placebos because participants will compare their own experiences over time.

Official TitleEffectiveness of Chilipad in Enhancing Sleep Quality & Wellbeing 
NCT06614530
Principal SponsorEfforia, Inc
Study ContactMatthew M Amsden, MBA
Last updated: December 13, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
120 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 21 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Users will receive a 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 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.
Study Objectives
Primary Objectives

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

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

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

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 Objectives

The Wellbeing Survey used in this study is a validated tool designed to assess various aspects of participants\' psychological well-being and quality of life. It includes a series of statements to which participants respond on a seven-point scale, measuring their level of agreement. This survey captures dimensions such as emotional and mental health, helping to track changes in well-being throughout the study.

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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