Reports on Sleep Quality and Thermoregulation Among Veterans

Study Overview
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Brief Summary
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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
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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

Official Title
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Reports on Sleep Quality and Thermoregulation Among Veterans

Conditions
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Sleep Disturbance

Intervention / Treatment
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* Device: chilipad


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chilipad Arm<br>Subjects will use chilipad nightly for 5 weeks | Device: chilipad<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chilipad, Sleep disorders