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Reports on Sleep Quality and Thermoregulation Among Veterans (ReSQuTheVets)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04236661
Recruitment Status : Not yet recruiting
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Sleep Disturbance Device: chilipad Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reports on Sleep Quality and Thermoregulation Among Veterans
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders

Arm Intervention/treatment
Experimental: Chilipad Arm
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.




Primary Outcome Measures :
  1. PROMIS Sleep Related Impairment Short Form [ Time Frame: 5-week prior 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

  2. PROMIS Sleep Related Impairment Short Form [ Time Frame: 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 :
  1. OURA ring total sleep metric [ Time Frame: 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.

  2. OURA ring REM metric [ Time Frame: 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.

  3. OURA ring DEEP sleep metric [ Time Frame: 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.

  4. OURA ring Efficiency metric [ Time Frame: 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.

  5. OURA ring latency metric [ Time Frame: 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.

  6. OURA ring timing metric [ Time Frame: 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.

  7. OURA ring sleep score metric [ Time Frame: 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.

  8. OURA ring resting heart rate [ Time Frame: 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.

  9. OURA ring respiration rate [ Time Frame: 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.

  10. OURA ring readiness score [ Time Frame: 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.

  11. OURA ring Skin temperature [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236661


Contacts
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Contact: Remy Coeytaux, MD, PhD 336-716-7238 rcoeytaux@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
Contact: Remy Coeytaux, MD, PhD    336-716-7238    rcoeytaux@wakehealth.edu   
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Remy Coeytaux, MD, PhD Wake Forest University Health Sciences

Additional Information:
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04236661    
Other Study ID Numbers: New Chilipad
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Wake Forest University Health Sciences:
chilipad
Sleep disorders
Additional relevant MeSH terms:
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Dyssomnias
Sleep Wake Disorders
Parasomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms