SleepNCT04257825
Use of Temperature Controlling Mattress Pad for Sleep Improvement
A study testing Chili Sleep System in people with Sleep, run by ProofPilot at 1 site in United States.
Trial summary
A dual arm interventional study in which chliipad and ooler sleep system users voluntarily opt out of using their device for 2 out of 4 weeks. Assessments of sleep via self report and Oura Ring sleep quality and duration. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Chili Sleep System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2019to 26 Feb 2020
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- has a chili sleep system
- has an Oura Ring
Who cannot join
- medically treatable issue
- recent injury
- expected significant travel over study period
Trial locations and contacts
1 site in 1 country.
United States1 site
ProofPilot (Virtual Study: https://p.proofpilot.com)
New York, New York, 10003
About this study
Official title: The Chili + OURA Sleep Study
A dual arm interventional study in which chliipad and ooler sleep system users voluntarily opt out of using their device for 2 out of 4 weeks. Assessments of sleep via self report and Oura Ring sleep quality and duration.
- Conditions
- Sleep
- Being tested
- Chili Sleep System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chili Sleep SystemDevice
A mattress pad that cools or warms bed to maintain a constant temperature.
| Study group | Role | What they receive |
|---|---|---|
| Initial Off | Other | Individuals were asked to not use their device on weeks 1 and 3 of the study. They were asked to use their device on weeks 2 and 4. Receives: Device: Chili Sleep System |
| Initial On | Other | Individuals were asked to not use their device on weeks 2 and 4 of the study. They were asked to use their device on weeks 1 and 3. Receives: Device: Chili Sleep System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Deep Sleep as Measured by Oura Ring
Oura Ring is a connected health device worn on the finger that measures sleep. Deep sleep summaries per day will be compared between week 1 and week 2.
Measured: From week 1 to week 2
Change in self-reported sleep quality via Jenkins Sleep Scale
A 8 item self-assessment questionnaire of sleep quality.
Measured: From week 1 to week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start31 Oct 2019
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In the four week study, participants were randomized into multiple arms, and asked to not use their device for 1 week, and then use it the next. Arms alternated back and forth.
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProofPilot
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kryo Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257825
- Sponsor's protocol ID
- 2206
- Status last verified
- Feb 2020
- First submitted
- 25 Jan 2020
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no current plans to make data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Chili + OURA Sleep Study
- ClinicalTrials.gov ID
- NCT04257825
- Acronym / sponsor ID
- 2206
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- ProofPilotIndustry (pharma, biotech, devices)
- Collaborators
- Kryo Inc
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 6 Feb 2020 (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.
A dual arm interventional study in which chliipad and ooler sleep system users voluntarily opt out of using their device for 2 out of 4 weeks. Assessments of sleep via self report and Oura Ring sleep quality and duration.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In the four week study, participants were randomized into multiple arms, and asked to not use their device for 1 week, and then use it the next. Arms alternated back and forth.
| Arm | Type | Receives |
|---|---|---|
| Initial Off | Other | Device: Chili Sleep SystemIndividuals were asked to not use their device on weeks 1 and 3 of the study. They were asked to use their device on weeks 2 and 4. |
| Initial On | Other | Device: Chili Sleep SystemIndividuals were asked to not use their device on weeks 2 and 4 of the study. They were asked to use their device on weeks 1 and 3. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- has a chili sleep system
- has an Oura Ring
Key exclusion criteria (3 listed)
- medically treatable issue
- recent injury
- expected significant travel over study period
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 |
|---|---|---|
| Chili Sleep SystemA mattress pad that cools or warms bed to maintain a constant temperature. | Device | Initial Off, Initial On |
Primary outcome
Change in Deep Sleep as Measured by Oura Ring
Time frame: From week 1 to week 2
Oura Ring is a connected health device worn on the finger that measures sleep. Deep sleep summaries per day will be compared between week 1 and week 2.
Change in self-reported sleep quality via Jenkins Sleep Scale
Time frame: From week 1 to week 2
A 8 item self-assessment questionnaire of sleep quality.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No. There are no current plans to make data available to other researchers.
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Healthy Adult Participants
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chili Sleep System in people with Sleep, run by ProofPilot 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 15 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Deep Sleep as Measured by Oura Ring (time frame: From week 1 to week 2). The study lists 2 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 15 Sep 2026.