Use of Temperature Controlling Mattress Pad for Sleep Improvement

NCT04257825 | Unknown

• 1 other identifier: 2206
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep

Outcome Measures

Primary Outcomes (2)

• Change in Deep Sleep as Measured by Oura Ring

  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

  A 8 item self-assessment questionnaire of sleep quality.

  From week 1 to week 2

Study Arms (2)

Initial Off

OTHER

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

Initial On

OTHER

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

Interventions

Chili Sleep System DEVICE

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

Initial Off; Initial On

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• has a chili sleep system
• has an Oura Ring

You may not qualify if:

• medically treatable issue
• recent injury
• expected significant travel over study period

Sponsors & Collaborators

• ProofPilot: lead
• Kryo Inc: collaborator

Study Sites (1)

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

New York, New York, 10003, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There was no masking in this study.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 25, 2020
• First Posted: February 6, 2020
• Study Start: October 31, 2019
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: February 6, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)