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study team unable to start up study at this time
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chilipad Arm | Experimental | Subjects will use chilipad nightly for 5 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chilipad | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Remy Coeytaux, MD, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
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| Label | URL |
|---|---|
| describes oura ring outcome measures in detail | View source |
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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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
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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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |