RECRUITING

Non-invasive Nerve Stimulation and Sleep

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

People often have difficulty sleeping. Reasons are many. But, difficulty falling and staying asleep are common issues. Sleep difficulties are common in disorders such as Post Traumatic Stress Disorder. Current treatments for sleep difficulties are not effective for everyone. Better treatments are needed. In this study, the investigators are testing two nerve stimulation locations that may impact brain function in such a way that sleep is improved.

Official Title

Transcutaneous Vagal Nerve Stimulation Improvement of Sleep Quality in Veterans With PTSD With or Without History of Mild TBI

Quick Facts

Study Start:2020-01-30
Study Completion:2024-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04021537

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Condition: Hx VA/DOD criteria PTSD w or w/o mTBI and current sig symptoms of PTSD
  2. * English fluency
  1. * Neurological injuries or conditions aside from mTBI that may affect outcome variables and/or other variables in the study
  2. * Psychiatric issues that are unlikely to be related to trauma that may affect outcomes and/or other variables in the
  3. * e.g., schizophrenia
  4. * Untreated sleep apnea
  5. * CPAP controlled sleep apnea is okay
  6. * Major uncorrected sensory deficit
  7. * Current drug or alcohol abuse
  8. * Drug abuse within the last two months will result in exclusion or delay
  9. * Marijuana use or alcohol intoxication within 2 weeks of study will be acceptable
  10. * No pregnancy

Contacts and Locations

Study Contact

John B Williamson, PhD
CONTACT
(352) 376-1611
john.williamson2@va.gov
Richard B Berry, MD
CONTACT
(352) 376-1611
richard.berry@va.gov

Principal Investigator

John B. Williamson, PhD
PRINCIPAL_INVESTIGATOR
North Florida/South Georgia Veterans Health System, Gainesville, FL

Study Locations (Sites)

North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608-1135
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • John B. Williamson, PhD, PRINCIPAL_INVESTIGATOR, North Florida/South Georgia Veterans Health System, Gainesville, FL

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-30
Study Completion Date2024-10-31

Study Record Updates

Study Start Date2020-01-30
Study Completion Date2024-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • PTSD