Chilipad for Sleep and Symptoms of PTSD

PTSD Clinical Trial

Official title:

Chilipad for Sleep and Symptoms of PTSD

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03924297
• Other study ID #: IRB00057589
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• PTSD

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

External Links

•   describes oura ring outcome measures in detail