Reports on Sleep Quality and Thermoregulation Among Veterans (ReSQuTheVets)

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

Study Overview

• Status: Withdrawn
• Conditions: Sleep Disturbance
• Intervention / Treatment: Device: chilipad

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

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chilipad Arm; Subjects will use chilipad nightly for 5 weeks	Device: chilipad; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5-week prior intervention
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	5-week after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Nightly for 5 weeks
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.	Nightly for 5 weeks
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.	Nightly for 5 weeks
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.	Nightly for 5 weeks
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.	Nightly for 5 weeks
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.	Nightly for 5 weeks
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.	Nightly for 5 weeks
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.	Nightly for 5 weeks
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.	Nightly for 5 weeks
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.	Nightly for 5 weeks
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.	Nightly for 5 weeks

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences

Publications and helpful links

Helpful Links

• describes oura ring outcome measures in detail

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: January 17, 2020
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (Actual): January 22, 2020

Study Record Updates

• Last Update Posted (Actual): August 7, 2020
• Last Update Submitted That Met QC Criteria: August 5, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Sleep disorders; chilipad
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: New Chilipad

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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