Chilipad for Sleep and Symptoms of PTSD

NCT03924297 | Withdrawn FDA Device

• 1 other identifier: IRB00057589
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

PTSD

Keywords

chilipad

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• PROMIS anxiety short form

  5-week prior intervention

• PROMIS Anger Short form

  5-week after intervention

• OURA ring total sleep metric

  Nightly for 5 weeks

• OURA ring REM metric

  Nightly for 5 weeks

• OURA ring DEEP sleep metric

  Nightly for 5 weeks

Study Arms (1)

Chilipad Arm

EXPERIMENTAL

Subjects will use chilipad nightly for 5 weeks

Device: chilipad

Interventions

chilipad DEVICE

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.

Chilipad Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Related Links

• describes oura ring outcome measures in detail

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Remy Coeytaux, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 23, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: January 3, 2020

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)