SleepNCT06614530
Effectiveness of Chilipad in Enhancing Sleep Quality & Wellbeing
A study testing Chilipad Docker Pro in people with Sleep and Wellness, run by Efforia, Inc.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- What is being tested?
- Chilipad Docker Pro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- in the United States
- recent purchaser or customer of Sleep.me
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Being tested
- Chilipad Docker Pro
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chilipad Docker ProDevice
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 group | Role | What they receive |
|---|---|---|
| Chilipad Docker Pro Interventional Arm | Experimental | Users will receive a Chilipad Docker Pro. Receives: Device: Chilipad Docker Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days
Secondary outcomes (2)
Wellbeing Survey: Wellbeing Survey Score
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.
Measured: 30 Day
36-Item Short Form Survey Instrument (SF-36): 36-Item Short Form Survey Instrument (SF-36) Score
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: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (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.
- More trials run by Efforia, IncThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Efforia, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew M Amsden, MBA, Principal investigator, Efforia, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614530
- Sponsor's protocol ID
- 13223
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Chilipad in Enhancing Sleep Quality & Wellbeing
- ClinicalTrials.gov ID
- NCT06614530
- Acronym / sponsor ID
- 13223
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Efforia, IncIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 26 Sep 2024 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chilipad Docker Pro Interventional Arm | Experimental | Device: Chilipad Docker ProUsers will receive a Chilipad Docker Pro. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- in the United States
- recent purchaser or customer of Sleep.me
Key exclusion criteria (8 listed)
- 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
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 Docker ProThe 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. | Device | Chilipad Docker Pro Interventional Arm |
Primary outcome
Deep Sleep as Measured by Sleep Me Sleep Tracker
Time frame: Day 30
A non-wearable sleep tracker that is placed under the mattress at heart level and automatically tracks sleep information.
REM Sleep as Measured by Sleep Me Sleep Tracker
Time frame: Day 30
A non-wearable sleep tracker that is placed under the mattress at heart level and automatically tracks sleep information.
Time to Sleep as Measured by Sleep Me Sleep Tracker
Time frame: Day 30
A non-wearable sleep tracker that is placed under the mattress at heart level and automatically tracks sleep information.
PROMIS Sleep Disturbance Scale: PROMIS-SD Score
Time frame: 30 days
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.
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Matthew M Amsden, MBA principal investigator
Efforia, Inc
Questions about this trial
What is this clinical trial studying?
A study testing Chilipad Docker Pro in people with Sleep and Wellness, run by Efforia, Inc.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew M Amsden, MBA (646-679-2479 ext. (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?
Deep Sleep as Measured by Sleep Me Sleep Tracker (time frame: Day 30). The study lists 4 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 26 Sep 2024.