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Chilipad for Sleep and Symptoms of PTSD

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Withdrawn

Conditions

PTSD

Treatments

Device: chilipad

Study type

Interventional

Funder types

Other

Identifiers

NCT03924297
IRB00057589

Details and patient eligibility

About

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

Full 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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Chilipad Arm
Experimental group
Description:
Subjects will use chilipad nightly for 5 weeks
Treatment:
Device: chilipad

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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