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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 : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE April 18, 2019
First Posted Date  ICMJE April 23, 2019
Last Update Posted Date June 4, 2019
Estimated Study Start Date  ICMJE July 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03924297 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chilipad for Sleep and Symptoms of PTSD
Official Title  ICMJE Chilipad for Sleep and Symptoms of PTSD
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE PTSD
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Chilipad Arm
Subjects in this arm will use chilipad nightly for 5 weeks
Intervention: Device: chilipad
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 18, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Remy Coeytaux, MD, PhD 336-716-7238 rcoeytaux@wakehealth.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03924297
Other Study ID Numbers  ICMJE IRB00057589
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Remy Coeytaux, MD, PhD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP