Reports on Sleep Quality and Thermoregulation Among Veterans

Sleep Disturbance Clinical Trial

— ReSQuTheVets  

Official title:

Reports on Sleep Quality and Thermoregulation Among Veterans

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04236661
• Other study ID #: New Chilipad
• Status: Withdrawn
• Phase: N/A
• Start date: July 2020
• Est. completion date: November 2020

Study information

• Verified date: December 2019
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disturbance

Intervention

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.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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.	Nightly for 5 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   describes oura ring outcome measures in detail