Chilipad for Sleep and Symptoms of PTSD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to obtain pilot data in preparation for future research designed to formally evaluate the effectiveness of the Chilipad for patients with PTSD

Detailed Description
-----------------
This is a prospective cohort, before-after trial. 20 subjects with PTSD or PTSD symptoms (per patient report) will use the Chilipad nightly for 5 weeks after completing a short battery of PROMIS questionnaires. During the 5-week study intervention, subjects will also wear an OURA ring on a finger. The OURA week measures sleep duration and quality. 5 weeks after study enrollment, patients will repeat the battery or PROMIS questionnaires and will return the Chilipad and OURA rings, both of which will be provided free of charge by the Chilipad and OURA manufacturers

Official Title
-----------------
Chilipad for Sleep and Symptoms of PTSD

Conditions
-----------------
PTSD

Intervention / Treatment
-----------------
* Device: chilipad


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have seen the study PI (Remy Coeytaux, MD, PhD) for an integrative medicine consultation between September 1, 2018 and April 30, 2019 and who report having been diagnoses with PTSD or who believe they may have PTSD or PTSD-related symptoms are eligible to participate. Exclusion Criteria: No exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Twenty subjects with PTSD will use the Chilipad nightly for 5 weeks. The subjects will be given an OURA ring to measure sleep duration and 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?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Sleep Related Impairment Short Form | PROMIS sleep related impairment short form is a questionnaire that ranges in score from 8-40; the lower the score, the better the outcome. | 5-week prior intervention | 
| PROMIS Sleep Related Impairment Short Form | PROMIS sleep related impairment short form is a questionnaire that ranges in score from 8-40; the lower the score, the better the outcome. | 5-week after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS anxiety short form | PROMIS anxiety short form is a questionnaire that ranges in score from 8-40; the lower the score, the better the outcome. | 5-week prior intervention | 
| PROMIS Anger Short form | the PROMIS anger short form is a questionnaire that ranges in score from 5-25; the lower the score, the better the outcome. | 5-week after intervention | 
| 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 heart rate variability | OURA is a ring that is worn on a finger and collects information about the quality and duration of sleep. The heart rate variability 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 lowest resting heart rate | OURA is a ring that is worn on a finger and collects information about the quality and duration of sleep. The lowest resting heart 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chilipad