SleepNCT07281963
Chilipad Sleep Optimization Study
A study testing Chilipad Dock Pro Bed Cooling System and Sleep Tracker in people with Sleep, run by Efforia, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Chilipad Dock Pro Bed Cooling System and Sleep Tracker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2025to 25 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Can read and understand English.
- US resident.
- Willing and able to follow the requirements of the protocol.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Efforia
New York, New York, 10003
Matthew Amsden, (646) 679-2479, help@efforia.com
About this study
This study evaluates the Chilipad Dock Pro Bed Cooling System and Sleep Tracker, examining how bed temperature influences sleep quality and overall well-being.
Read the detailed description
This remotely administered decentralized trial is designed to rigorously evaluate the impact of the Chilipad Dock Pro Bed Cooling System on sleep quality and overall well-being. In a world where optimal sleep remains elusive for many, this study seeks to provide evidence-based insights into how temperature regulation can significantly affect restful nights. Leveraging the potential of the Chilipad Dock Pro Bed Cooling System, which offers personalized temperature settings aimed at enhancing the sleep environment, this research focuses on quantifying its effectiveness through scientifically validated metrics.
Participants in this study will engage in a comprehensive assessment process, utilizing the PROMIS Sleep Disturbance Scale, Well-being Survey, and SF-36 as primary tools for measuring outcomes. By collecting data remotely from participants in their natural sleep settings, this trial aims to offer a real-world evaluation of the system's capability to improve sleep quality. From baseline to endpoint, the study will monitor changes in sleep disturbance, overall well-being, and health-related quality of life, providing a robust dataset for analysis.
The overarching objective of this research is to empower participants with concrete, science-backed data on the impact of the Chilipad Dock Pro Bed Cooling System on their sleep and well-being. By the conclusion of the study, participants will have access to measurable insights into how the system has influenced their sleep patterns and quality of life, thereby aiding in informed decision-making for enhanced health outcomes.
Furthermore, this study stands to significantly contribute to the broader scientific and healthcare communities by establishing a clear link between temperature regulation during sleep and sleep quality improvements. In addressing the gap between anecdotal evidence and scientific validation, the findings from this research are anticipated to underscore the importance of sleep environment optimization. By demonstrating the efficacy of the Chilipad Dock Pro Bed Cooling System through significant changes in validated measures of sleep and well-being, this study could pave the way for revolutionary approaches in sleep health management, acknowledging the limitations posed by individual sleep needs variability and external environmental factors.
- Conditions
- Sleep
- Being tested
- Chilipad Dock Pro Bed Cooling System and Sleep Tracker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chilipad Dock Pro Bed Cooling System and Sleep TrackerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single arm where participants act as their own control | Experimental | Single arm where participants act as their own control Receives: Device: Chilipad Dock Pro Bed Cooling System and Sleep Tracker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change from baseline (Day 1) in SF-36 at 4 weeks after the start of the intervention (Day 29-31)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start25 Sep 2025
- Primary completion25 Sep 2026 (estimated)
- Study completion25 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Arm observational where participants act as their own control
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Efforia, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281963
- Sponsor's protocol ID
- 13228
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chilipad Sleep Optimization Study
- ClinicalTrials.gov ID
- NCT07281963
- Acronym / sponsor ID
- 13228
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Efforia, IncIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 25 Sep 2026 (estimated)
- Study completion
- 25 Sep 2026 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the Chilipad Dock Pro Bed Cooling System and Sleep Tracker, examining how bed temperature influences sleep quality and overall well-being.
Detailed description
This remotely administered decentralized trial is designed to rigorously evaluate the impact of the Chilipad Dock Pro Bed Cooling System on sleep quality and overall well-being. In a world where optimal sleep remains elusive for many, this study seeks to provide evidence-based insights into how temperature regulation can significantly affect restful nights. Leveraging the potential of the Chilipad Dock Pro Bed Cooling System, which offers personalized temperature settings aimed at enhancing the sleep environment, this research focuses on quantifying its effectiveness through scientifically validated metrics.
Participants in this study will engage in a comprehensive assessment process, utilizing the PROMIS Sleep Disturbance Scale, Well-being Survey, and SF-36 as primary tools for measuring outcomes. By collecting data remotely from participants in their natural sleep settings, this trial aims to offer a real-world evaluation of the system's capability to improve sleep quality. From baseline to endpoint, the study will monitor changes in sleep disturbance, overall well-being, and health-related quality of life, providing a robust dataset for analysis.
The overarching objective of this research is to empower participants with concrete, science-backed data on the impact of the Chilipad Dock Pro Bed Cooling System on their sleep and well-being. By the conclusion of the study, participants will have access to measurable insights into how the system has influenced their sleep patterns and quality of life, thereby aiding in informed decision-making for enhanced health outcomes.
Furthermore, this study stands to significantly contribute to the broader scientific and healthcare communities by establishing a clear link between temperature regulation during sleep and sleep quality improvements. In addressing the gap between anecdotal evidence and scientific validation, the findings from this research are anticipated to underscore the importance of sleep environment optimization. By demonstrating the efficacy of the Chilipad Dock Pro Bed Cooling System through significant changes in validated measures of sleep and well-being, this study could pave the way for revolutionary approaches in sleep health management, acknowledging the limitations posed by individual sleep needs variability and external environmental factors.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Arm observational where participants act as their own control
| Arm | Type | Receives |
|---|---|---|
| Single arm where participants act as their own control | Experimental | Device: Chilipad Dock Pro Bed Cooling System and Sleep TrackerSingle arm where participants act as their own control |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Can read and understand English.
- US resident.
- Willing and able to follow the requirements of the protocol.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chilipad Dock Pro Bed Cooling System and Sleep TrackerThe 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. | Device | Single arm where participants act as their own control |
Primary outcome
PROMIS Sleep Disturbance Scale
Time frame: Change from baseline (Day 1-3) in PROMIS Sleep Disturbance Scale at 4 weeks after the start of the intervention (Day 27-33)
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.
Well-being Survey
Time frame: Change from baseline (Day 1-3) in Well-being Survey at 4 weeks after the start of the intervention (Day 27-33)
Please answer the following questions to assess your well-being.
36-Item Short Form Survey Instrument (SF-36)
Time frame: Change from baseline (Day 1) in SF-36 at 4 weeks after the start of the intervention (Day 29-31)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Additional information and join instructions on EfforiaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chilipad Dock Pro Bed Cooling System and Sleep Tracker in people with Sleep, run by Efforia, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Amsden (646-679-2479, help@efforia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Sleep Disturbance Scale (time frame: Change from baseline (Day 1-3) in PROMIS Sleep Disturbance Scale at 4 weeks after the start of the intervention (Day 27-33)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.