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Reports on Sleep Quality and Thermoregulation Among Veterans (ReSQuTheVets)

Primary Purpose

Sleep Disturbance

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
chilipad
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disturbance focused on measuring chilipad, Sleep disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult male and female veteran patients (> 18 years of age)
  • Self-report of sleep disturbance, defined as "sleep of poor quality, timing, efficiency, or duration"

Exclusion Criteria:

  • Non-adult patients < 18 years of age.
  • Patients with chart documentation or self-report of illegal drug use, impaired orientation and cognition or currently incarcerated.
  • Initiated CAM or non-CAM treatments for sleep disturbance in the last 4 weeks.
  • Changed dose of a CAM or non-CAM treatments for sleep disturbance in the last 4 weeks.
  • Initiated antidepressants in the last 3 months.
  • Changed of an antidepressant in the last 3 months.
  • Patients who describe their health as fair or poor.

Sites / Locations

  • Wake Forest Baptist Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chilipad Arm

Arm Description

Subjects will use chilipad nightly for 5 weeks

Outcomes

Primary Outcome Measures

PROMIS Sleep Related Impairment Short Form
PROMIS sleep related impairment short form is a questionnaire with 8-item 5-point Likert rating scale survey reflecting DSM-5 for sleep disturbance. The raw score on 8 items is determined, summed for a raw score, then a T-score table is utilized to compare with the subject's individual score. The result, rounded to the nearest whole number determines the score. The survey T-scores are interpreted as: < 55 = none to slight; 55.0 - 59.9 = mild; 60.0 - 69.9 = moderate; and > 70 = severe
PROMIS Sleep Related Impairment Short Form
PROMIS sleep related impairment short form is a questionnaire with 8-item 5-point Likert rating scale survey reflecting DSM-5 for sleep disturbance. The raw score on 8 items is determined, summed for a raw score, then a T-score table is utilized to compare with the subject's individual score. The result, rounded to the nearest whole number determines the score. The survey T-scores are interpreted as: < 55 = none to slight; 55.0 - 59.9 = mild; 60.0 - 69.9 = moderate; and > 70 = severe

Secondary Outcome Measures

OURA ring total sleep metric
OURA is a ring that is worn on a finger and collects information about the quality and duration of sleep. The total sleep metric will show hours of sleep each night.
OURA ring REM metric
OURA is a ring that is worn on a finger and collects information about the quality and duration of sleep. The total REM metric will show the total amount of REM sleep each night.
OURA ring DEEP sleep metric
OURA is a ring that is worn on a finger and collects information about the quality and duration of sleep. The DEEP sleep metric will show the number of hours of deep sleep each night.
OURA ring Efficiency metric
OURA is a ring that is worn on a finger and collects information about the quality and duration of sleep. Efficiency means the percentage of time spent sleeping while in bed.
OURA ring latency metric
OURA is a ring that is worn on a finger and collects information about the quality and duration of sleep. Latency is the amount of time it takes a study participant to fall to sleep.
OURA ring timing metric
OURA is a ring that is worn on a finger and collects information about the quality and duration of sleep. The timing records individual circadian rhythms.
OURA ring sleep score metric
OURA is a ring that is worn on a finger and collects information about the quality and duration of sleep. The sleep score metric will be determined by total sleep, efficiency, disturbances, REM sleep, deep sleep, sleep latency, sleep timing and light sleep.The sleep score ranges from 0-100. Higher scores denotes better outcomes.
OURA ring resting heart rate
OURA is a ring that is worn on a finger and collects information about the quality and duration of sleep. The resting heart rate will be recorded.
OURA ring respiration rate
OURA is a ring that is worn on a finger and collects information about the quality and duration of sleep. The respiration rate will be recorded.
OURA ring readiness score
OURA is a ring that is worn on a finger and collects information about the quality and duration of sleep. The readiness score is calculated taking in account sleep balance, previous day activity, activity balance, body temperature, resting heart rate (rhr), recovery index . Score will be between 0 and 100. A lower score indicates a worse outcome.
OURA ring Skin temperature
OURA is a ring that is worn on a finger and collects information about the quality and duration of sleep. The OURA ring will measure skin temperature.

Full Information

First Posted
January 17, 2020
Last Updated
August 5, 2020
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04236661
Brief Title
Reports on Sleep Quality and Thermoregulation Among Veterans
Acronym
ReSQuTheVets
Official Title
Reports on Sleep Quality and Thermoregulation Among Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Withdrawn
Why Stopped
study team unable to start up study at this time
Study Start Date
July 2020 (Anticipated)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To assess and compare the quality of sleep self- reported by veterans with sleep disorders before and after use of the Chilipad cooling mattress pad
Detailed Description
A non-randomized convenience sampling study of N=20 adult male or female veterans (> 18 years of age) with self-reporting sleep disturbance and will utilize a Chilipad cooling mattress for the 5-week study period

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance
Keywords
chilipad, Sleep disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Twenty subjects with self-reporting sleep disturbance will use the Chilipad cooling mattress for 5 weeks. The subjects will be given a Diary to complete tracking sleep quality during the 5 weeks. Subjects will also be given questionnaires before and after the sleep study part of the study to measure changes
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chilipad Arm
Arm Type
Experimental
Arm Description
Subjects will use chilipad nightly for 5 weeks
Intervention Type
Device
Intervention Name(s)
chilipad
Intervention Description
Chilipad is a commercially available pad designed to be placed between the top of a mattress and bed sheets. It allows for precise temperature regulation in one's bed.
Primary Outcome Measure Information:
Title
PROMIS Sleep Related Impairment Short Form
Description
PROMIS sleep related impairment short form is a questionnaire with 8-item 5-point Likert rating scale survey reflecting DSM-5 for sleep disturbance. The raw score on 8 items is determined, summed for a raw score, then a T-score table is utilized to compare with the subject's individual score. The result, rounded to the nearest whole number determines the score. The survey T-scores are interpreted as: < 55 = none to slight; 55.0 - 59.9 = mild; 60.0 - 69.9 = moderate; and > 70 = severe
Time Frame
5-week prior intervention
Title
PROMIS Sleep Related Impairment Short Form
Description
PROMIS sleep related impairment short form is a questionnaire with 8-item 5-point Likert rating scale survey reflecting DSM-5 for sleep disturbance. The raw score on 8 items is determined, summed for a raw score, then a T-score table is utilized to compare with the subject's individual score. The result, rounded to the nearest whole number determines the score. The survey T-scores are interpreted as: < 55 = none to slight; 55.0 - 59.9 = mild; 60.0 - 69.9 = moderate; and > 70 = severe
Time Frame
5-week after intervention
Secondary Outcome Measure Information:
Title
OURA ring total sleep metric
Description
OURA is a ring that is worn on a finger and collects information about the quality and duration of sleep. The total sleep metric will show hours of sleep each night.
Time Frame
Nightly for 5 weeks
Title
OURA ring REM metric
Description
OURA is a ring that is worn on a finger and collects information about the quality and duration of sleep. The total REM metric will show the total amount of REM sleep each night.
Time Frame
Nightly for 5 weeks
Title
OURA ring DEEP sleep metric
Description
OURA is a ring that is worn on a finger and collects information about the quality and duration of sleep. The DEEP sleep metric will show the number of hours of deep sleep each night.
Time Frame
Nightly for 5 weeks
Title
OURA ring Efficiency metric
Description
OURA is a ring that is worn on a finger and collects information about the quality and duration of sleep. Efficiency means the percentage of time spent sleeping while in bed.
Time Frame
Nightly for 5 weeks
Title
OURA ring latency metric
Description
OURA is a ring that is worn on a finger and collects information about the quality and duration of sleep. Latency is the amount of time it takes a study participant to fall to sleep.
Time Frame
Nightly for 5 weeks
Title
OURA ring timing metric
Description
OURA is a ring that is worn on a finger and collects information about the quality and duration of sleep. The timing records individual circadian rhythms.
Time Frame
Nightly for 5 weeks
Title
OURA ring sleep score metric
Description
OURA is a ring that is worn on a finger and collects information about the quality and duration of sleep. The sleep score metric will be determined by total sleep, efficiency, disturbances, REM sleep, deep sleep, sleep latency, sleep timing and light sleep.The sleep score ranges from 0-100. Higher scores denotes better outcomes.
Time Frame
Nightly for 5 weeks
Title
OURA ring resting heart rate
Description
OURA is a ring that is worn on a finger and collects information about the quality and duration of sleep. The resting heart rate will be recorded.
Time Frame
Nightly for 5 weeks
Title
OURA ring respiration rate
Description
OURA is a ring that is worn on a finger and collects information about the quality and duration of sleep. The respiration rate will be recorded.
Time Frame
Nightly for 5 weeks
Title
OURA ring readiness score
Description
OURA is a ring that is worn on a finger and collects information about the quality and duration of sleep. The readiness score is calculated taking in account sleep balance, previous day activity, activity balance, body temperature, resting heart rate (rhr), recovery index . Score will be between 0 and 100. A lower score indicates a worse outcome.
Time Frame
Nightly for 5 weeks
Title
OURA ring Skin temperature
Description
OURA is a ring that is worn on a finger and collects information about the quality and duration of sleep. The OURA ring will measure skin temperature.
Time Frame
Nightly for 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult male and female veteran patients (> 18 years of age) Self-report of sleep disturbance, defined as "sleep of poor quality, timing, efficiency, or duration" Exclusion Criteria: Non-adult patients < 18 years of age. Patients with chart documentation or self-report of illegal drug use, impaired orientation and cognition or currently incarcerated. Initiated CAM or non-CAM treatments for sleep disturbance in the last 4 weeks. Changed dose of a CAM or non-CAM treatments for sleep disturbance in the last 4 weeks. Initiated antidepressants in the last 3 months. Changed of an antidepressant in the last 3 months. Patients who describe their health as fair or poor.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Remy Coeytaux, MD, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://ouraring.com/
Description
describes oura ring outcome measures in detail

Learn more about this trial

Reports on Sleep Quality and Thermoregulation Among Veterans

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