Use of Temperature Controlling Mattress Pad for Sleep Improvement

Not Applicable

• Conditions: Sleep
• Interventions: Device: Chili Sleep System

• Registration Number: NCT04257825
• Lead Sponsor: ProofPilot

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-31
• Study First Submitted: 2020-01-25
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-03
• Last Update Submitted: 2020-02-03
• Study First Posted: 2020-02-06
• Last Update Posted: 2020-02-06
• Primary Completion: 2020-02-28
• Study Completion: 2020-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 133

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Initial Off	Chili Sleep System	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.
Initial On	Chili Sleep System	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

ProofPilot (Virtual Study: https://p.proofpilot.com); 🇺🇸 New York, New York, United States