Use of Temperature Controlling Mattress Pad for Sleep Improvement

February 3, 2020 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

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

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

  • United States
    • New York
      • New York, New York, United States, 10003
        • Recruiting
        • ProofPilot (Virtual Study: https://p.proofpilot.com)
        • Contact:

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

Genders Eligible for Study

All

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
  • Masking: NONE

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.
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.

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

ProofPilot

Collaborators

Kryo Inc

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 (ANTICIPATED)

February 28, 2020

Study Completion (ANTICIPATED)

February 28, 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)

February 6, 2020

Last Update Submitted That Met QC Criteria

February 3, 2020

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.

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