Chilipad for Sleep and Symptoms of PTSD

Not Applicable

Withdrawn

• Conditions: PTSD
• Interventions: Device: chilipad

• Registration Number: NCT03924297
• Lead Sponsor: 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

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 Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-18
• Study First Submitted QC: 2019-04-18
• Study First Posted: 2019-04-23
• Study Start: 2019-09
• Last Update Submitted: 2019-12-31
• Last Update Posted: 2020-01-03
• Primary Completion: 2020-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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Exclusion Criteria

• No exclusion criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chilipad Arm	chilipad	Subjects will use chilipad nightly for 5 weeks

Primary Outcome Measures

Name	Time	Method
PROMIS Sleep Related Impairment Short Form	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

Name	Time	Method
OURA ring timing metric	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.
PROMIS Anger Short form	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 Efficiency metric	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 REM metric	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 latency metric	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 lowest resting heart rate	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.
PROMIS anxiety short form	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.
OURA ring total sleep metric	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 DEEP sleep metric	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 heart rate variability	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	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 sleep score metric	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	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 readiness score	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.

Trial Locations

Locations (1)

Wake Forest Baptist Health; 🇺🇸 Winston-Salem, North Carolina, United States