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Chilipad for Sleep and Symptoms of PTSD

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ClinicalTrials.gov Identifier: NCT03924297
Recruitment Status : Not yet recruiting
First Posted : April 23, 2019
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
The purpose of this study is to obtain pilot data in preparation for future research designed to formally evaluate the effectiveness of the Chilipad for patients with PTSD.

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

Detailed Description:
This is a prospective cohort, before-after trial. 20 subjects with PTSD or PTSD symptoms (per patient report) will use the Chilipad nightly for 5 weeks after completing a short battery of PROMIS questionnaires. During the 5-week study intervention, subjects will also wear an OURA ring on a finger. The OURA week measures sleep duration and quality. 5 weeks after study enrollment, patients will repeat the battery or PROMIS questionnaires and will return the Chilipad and OURA rings, both of which will be provided free of charge by the Chilipad and OURA manufacturers.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Twenty subjects with PTSD will use the Chilipad nightly for 5 weeks. The subjects will be given an OURA ring to measure sleep duration and 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: Chilipad for Sleep and Symptoms of PTSD
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
Experimental: Chilipad Arm
Subjects in this arm 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 that ranges in score from 8-40; the lower the score, the better the outcome.

  2. PROMIS Sleep Related Impairment Short Form [ Time Frame: 5-week after intervention ]
    PROMIS sleep related impairment short form is a questionnaire that ranges in score from 8-40; the lower the score, the better the outcome.


Secondary Outcome Measures :
  1. PROMIS anxiety short form [ Time Frame: 5-week prior intervention ]
    PROMIS anxiety short form is a questionnaire that ranges in score from 8-40; the lower the score, the better the outcome.

  2. PROMIS Anger Short form [ Time Frame: 5-week after intervention ]
    the PROMIS anger short form is a questionnaire that ranges in score from 5-25; the lower the score, the better the outcome.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. OURA ring heart rate variability [ 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 heart rate variability will be recorded.

  12. 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.

  13. OURA ring lowest 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 lowest resting heart rate will be recorded.

  14. 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.



Information from the National Library of Medicine

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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:

  • Patients who have seen the study PI (Remy Coeytaux, MD, PhD) for an integrative medicine consultation between September 1, 2018 and April 30, 2019 and who report having been diagnoses with PTSD or who believe they may have PTSD or PTSD-related symptoms are eligible to participate.

Exclusion Criteria:

  • No exclusion criteria

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): NCT03924297


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 Not yet recruiting
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: NCT03924297     History of Changes
Other Study ID Numbers: IRB00057589
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: April 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
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Wake Forest University Health Sciences:
chilipad