- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04257825
Use of Temperature Controlling Mattress Pad for Sleep Improvement
September 14, 2026 updated by: ProofPilot
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
133
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10003
- ProofPilot (Virtual Study: https://p.proofpilot.com)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- has a chili sleep system
- has an Oura Ring
Exclusion Criteria:
- medically treatable issue
- recent injury
- expected significant travel over study period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Initial Off
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.
|
A mattress pad that cools or warms bed to maintain a constant temperature.
|
|
Other: Initial On
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.
|
A mattress pad that cools or warms bed to maintain a constant temperature.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From week 1 to 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.
|
From week 1 to week 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 31, 2019
Primary Completion (Actual)
February 26, 2020
Study Completion (Actual)
February 26, 2020
Study Registration Dates
First Submitted
January 25, 2020
First Submitted That Met QC Criteria
February 3, 2020
First Posted (Actual)
February 6, 2020
Study Record Updates
Last Update Posted (Actual)
September 15, 2026
Last Update Submitted That Met QC Criteria
September 14, 2026
Last Verified
February 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 2206
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There are no current plans to make data available to other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.