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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03924297
Other study ID # IRB00057589
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 2019
Est. completion date September 2020

Study information

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

Clinical Trial 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


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


Recruitment information / eligibility

Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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 that ranges in score from 8-40; the lower the score, the better the outcome. 5-week prior intervention
Primary PROMIS Sleep Related Impairment Short Form PROMIS sleep related impairment short form is a questionnaire that ranges in score from 8-40; the lower the score, the better the outcome. 5-week after intervention
Secondary PROMIS anxiety short form PROMIS anxiety short form is a questionnaire that ranges in score from 8-40; the lower the score, the better the outcome. 5-week prior intervention
Secondary PROMIS Anger Short form the PROMIS anger short form is a questionnaire that ranges in score from 5-25; the lower the score, the better the outcome. 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 heart rate variability 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. 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 lowest resting heart rate 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. 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
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