An interventional study of chilipad in Sleep Disturbance, sponsored by Wake Forest University Health Sciences. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-07.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
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
324 studies on the registry are indexed under Dyssomnias; 51 are open to participants now.
Browse Dyssomnias studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
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Exclusion Criteria:
Subjects will use chilipad nightly for 5 weeks
Device: chilipad
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.
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Nightly for 5 weeks
Plan to share: No
This study is withdrawn, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences