Use of Temperature Controlling Mattress Pad for Sleep Improvement

NCT ID: NCT04257825

Last Updated: 2020-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-31

Study Completion Date

2020-02-28

Brief Summary

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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

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Conditions

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Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

There was no masking in this study.

Study Groups

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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.

Group Type OTHER

Chili Sleep System

Intervention Type DEVICE

A mattress pad that cools or warms bed to maintain a constant temperature.

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.

Group Type OTHER

Chili Sleep System

Intervention Type DEVICE

A mattress pad that cools or warms bed to maintain a constant temperature.

Interventions

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Chili Sleep System

A mattress pad that cools or warms bed to maintain a constant temperature.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* has a chili sleep system
* has an Oura Ring

Exclusion Criteria

* medically treatable issue
* recent injury
* expected significant travel over study period
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kryo Inc

UNKNOWN

Sponsor Role collaborator

ProofPilot

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ProofPilot (Virtual Study: https://p.proofpilot.com)

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Matthew Amsden

Role: primary

323-284-4626

Other Identifiers

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2206

Identifier Type: -

Identifier Source: org_study_id

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