Use of Temperature Controlling Mattress Pad for Sleep Improvement

• Sponsor: ProofPilot (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT04257825
• Collaborator: Kryo Inc (Other)
• Enrollment: 133
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 3.9
• Patients Per Site Per Month: 33.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sleep	Device: Chili Sleep System	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 133 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention 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.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)
• Masking Description: There was no masking in this study.
• Primary Purpose: Other
• Official Title: The Chili + OURA Sleep Study
• Actual Study Start Date: Oct 31, 2019
• Anticipated Primary Completion Date: Feb 28, 2020
• Anticipated Study Completion Date: Feb 28, 2020

Arms and Interventions

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.	Device: Chili Sleep System; 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.	Device: Chili Sleep System; A mattress pad that cools or warms bed to maintain a constant temperature.

Outcome Measures

Primary Outcome Measures

1. Change in Deep Sleep as Measured by Oura Ring [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.

2. Change in self-reported sleep quality via Jenkins Sleep Scale [From week 1 to week 2]

   A 8 item self-assessment questionnaire of sleep quality.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• has a chili sleep system

• has an Oura Ring

Exclusion Criteria:

• medically treatable issue

• recent injury

• expected significant travel over study period

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ProofPilot (Virtual Study: https://p.proofpilot.com)	New York	New York	United States	10003

Sponsors and Collaborators

• ProofPilot
• Kryo Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ProofPilot
• ClinicalTrials.gov Identifier: NCT04257825
• Other Study ID Numbers: 2206
• First Posted: Feb 6, 2020
• Last Update Posted: Feb 6, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 6, 2020