Clinical trial NCT03924297: Chilipad for Sleep and Symptoms of PTSD
Official title: Chilipad for Sleep and Symptoms of PTSD
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: PTSD
Keywords: chilipad
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-04-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: PROMIS Sleep Related Impairment Short Form
timeFrame: 5-week prior intervention
measure: PROMIS Sleep Related Impairment Short Form
timeFrame: 5-week after intervention
Secondary outcomes:
measure: PROMIS anxiety short form
timeFrame: 5-week prior intervention
measure: PROMIS Anger Short form
timeFrame: 5-week after intervention
measure: OURA ring total sleep metric
timeFrame: Nightly for 5 weeks
measure: OURA ring REM metric
timeFrame: Nightly for 5 weeks
measure: OURA ring DEEP sleep metric
timeFrame: Nightly for 5 weeks
measure: OURA ring Efficiency metric
timeFrame: Nightly for 5 weeks
measure: OURA ring latency metric
timeFrame: Nightly for 5 weeks
measure: OURA ring timing metric
timeFrame: Nightly for 5 weeks
measure: OURA ring sleep score metric
timeFrame: Nightly for 5 weeks
measure: OURA ring resting heart rate
timeFrame: Nightly for 5 weeks
measure: OURA ring heart rate variability
timeFrame: Nightly for 5 weeks
measure: OURA ring respiration rate
timeFrame: Nightly for 5 weeks
measure: OURA ring lowest resting heart rate
timeFrame: Nightly for 5 weeks
measure: OURA ring readiness score
timeFrame: Nightly for 5 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Remy Coeytaux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: