Clinical trial NCT04236661: Reports on Sleep Quality and Thermoregulation Among Veterans
Official title: Reports on Sleep Quality and Thermoregulation Among Veterans
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sleep Disturbance
Keywords: chilipad
Sleep disorders
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: PROMIS Sleep Related Impairment Short Form
timeFrame: 5-week prior intervention
measure: PROMIS Sleep Related Impairment Short Form
timeFrame: 5-week after intervention
Secondary outcomes:
measure: OURA ring total sleep metric
timeFrame: Nightly for 5 weeks
measure: OURA ring REM metric
timeFrame: Nightly for 5 weeks
measure: OURA ring DEEP sleep metric
timeFrame: Nightly for 5 weeks
measure: OURA ring Efficiency metric
timeFrame: Nightly for 5 weeks
measure: OURA ring latency metric
timeFrame: Nightly for 5 weeks
measure: OURA ring timing metric
timeFrame: Nightly for 5 weeks
measure: OURA ring sleep score metric
timeFrame: Nightly for 5 weeks
measure: OURA ring resting heart rate
timeFrame: Nightly for 5 weeks
measure: OURA ring respiration rate
timeFrame: Nightly for 5 weeks
measure: OURA ring readiness score
timeFrame: Nightly for 5 weeks
measure: OURA ring Skin temperature
timeFrame: Nightly for 5 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Remy Coeytaux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: