PTSD
Conditions
Keywords
chilipad
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
Interventions
DEVICEchilipad
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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Sleep Related Impairment Short Form | 5-week prior intervention | PROMIS sleep related impairment short form is a questionnaire that ranges in score from 8-40; the lower the score, the better the outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Anger Short form | 5-week after intervention | the PROMIS anger short form is a questionnaire that ranges in score from 5-25; the lower the score, the better the outcome. |
| OURA ring total sleep metric | Nightly for 5 weeks | 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 | Nightly for 5 weeks | 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 | Nightly for 5 weeks | 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 | Nightly for 5 weeks | 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 | Nightly for 5 weeks | 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. |
| PROMIS anxiety short form | 5-week prior intervention | PROMIS anxiety short form is a questionnaire that ranges in score from 8-40; the lower the score, the better the outcome. |
| OURA ring sleep score metric | Nightly for 5 weeks | 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 | Nightly for 5 weeks | 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 heart rate variability | Nightly for 5 weeks | 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. |
| OURA ring respiration rate | Nightly for 5 weeks | 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 lowest resting heart rate | Nightly for 5 weeks | 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. |
| OURA ring readiness score | Nightly for 5 weeks | 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 timing metric | Nightly for 5 weeks | 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. |
Countries
United States
Outcome results
None listed