Reports on Sleep Quality and Thermoregulation Among Veterans

Not Applicable

Withdrawn

• Conditions: Sleep Disturbance
• Interventions: Device: chilipad

• Registration Number: NCT04236661
• Lead Sponsor: Wake Forest University Health Sciences

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2019-12
• Study First Submitted: 2020-01-17
• Study First Submitted QC: 2020-01-17
• Study First Posted: 2020-01-22
• Study Start: 2020-07
• Last Update Submitted: 2020-08-05
• Last Update Posted: 2020-08-07
• Primary Completion: 2020-11
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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"

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chilipad Arm	chilipad	Subjects will use chilipad nightly for 5 weeks

Primary Outcome Measures

Name	Time	Method
PROMIS Sleep Related Impairment Short Form	5-week after 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 Outcome Measures

Name	Time	Method
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 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 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 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 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 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 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 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 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.

Trial Locations

Locations (1)

Wake Forest Baptist Health; 🇺🇸 Winston-Salem, North Carolina, United States