Sleep Disturbance
Conditions
Keywords
chilipad, Sleep disorders
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
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 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
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 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 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 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 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 Skin temperature | 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 OURA ring will measure skin temperature. |
| 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. |
Countries
United States
Outcome results
None listed