Chilipad for Sleep and Symptoms of PTSD

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

Study Overview

• Status: Withdrawn
• Conditions: PTSD
• Intervention / Treatment: Device: chilipad

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: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences

Publications and helpful links

Helpful Links

• describes oura ring outcome measures in detail

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2019
• Primary Completion (ANTICIPATED): September 1, 2020
• Study Completion (ANTICIPATED): September 1, 2020

Study Registration Dates

• First Submitted: April 18, 2019
• First Submitted That Met QC Criteria: April 18, 2019
• First Posted (ACTUAL): April 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 3, 2020
• Last Update Submitted That Met QC Criteria: December 31, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: chilipad
• Other Study ID Numbers: IRB00057589

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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