Post Traumatic Stress Disorder (PTSD), Sleep Disordered Breathing And Genetics: Effects On Cognition

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Stanford University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01120847
First received: May 7, 2010
Last updated: December 2, 2013
Last verified: December 2013

May 7, 2010
December 2, 2013
September 2004
December 2015   (final data collection date for primary outcome measure)
Rey Auditory Verbal Learning Test [ Time Frame: annually ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01120847 on ClinicalTrials.gov Archive Site
APOE status [ Time Frame: sample taken at entry into study. ] [ Designated as safety issue: No ]
APOE allele
Not Provided
Not Provided
Not Provided
 
Post Traumatic Stress Disorder (PTSD), Sleep Disordered Breathing And Genetics: Effects On Cognition
PTSD, Sleep Disordered Breathing And Genetics: Effects On Cognition

The current research program aims to study how sleep disordered breathing, age and genetics affect memory in older adult veterans with Posttraumatic Stress Disorder (PTSD).

The study will help researchers and clinicians better understand the relationship among PTSD, sleep disordered breathing, genetics and memory function.

The research project will clarify how sleep disordered breathing and Apolipoprotein (APOE) status affect cognitive decline in a population already at risk for accelerated decline-veterans with PTSD.

To fill this knowledge gap properly, we will conduct a longitudinal study and data include analytic techniques designed specifically to identify moderators and mediators of clinical change.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

blood or saliva

Non-Probability Sample

US war Veterans with PTSD and possible sleep problems

Stress Disorders, Post-Traumatic
Not Provided
  • Veterans with PTSD
    No intervention; this is an observational study.
  • Control group w/out PTSD
    No intervention; this is an observational study.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 55 years or older, male or female veterans of any racial or ethnic group.
  2. PTSD subjects will be positive for lifetime PTSD, related to any past lifetime traumatic experience and have a diagnosis of current, chronic PTSD by the Clinician Administered PTSD Scale (CAPS) criteria with current CAPS score > 40
  3. Capable of giving informed consent for the study
  4. Sufficient visual and auditory acuity for cognitive testing

Exclusion Criteria:

Psychiatric Exclusions:

  1. Current or lifetime history of any psychiatric disorder with psychotic features
  2. Current or lifetime bipolar disorder or delusional disorder
  3. Prominent suicidal or homicidal ideation
  4. Current exposure to trauma or recent exposure to trauma in the past 3 months.
  5. Currently or have within the past six months met DSM-IV criteria for drug or alcohol abuse or dependence (except nicotine).
  6. Presence of alcohol intoxication (by breathalyzer) or alcohol withdrawal (by exam) during testing
  7. Diagnosis of probable or possible dementia
  8. Mini-Mental State Exam (MMSE) < 23
  9. History of seizure disorder.

Medical/Medication Exclusions:

  1. Acute illness or unstable chronic illness (e.g., history of severe liver disease (cirrhosis, esophageal varices, ascites, portal hypertension, hepatic encephalopathy). Clinical or laboratory evidence of active hepatic disease will be recorded.
  2. History of neurologic (e.g., multiple sclerosis, seizure disorder, stroke, history of transient ischemic attacks) or systemic illness affecting central nervous system (CNS) function (e.g. liver failure, kidney failure, congestive heart failure, systemic cancer)
  3. Unstable or severe cardiovascular disease
  4. Unstable gastrointestinal disorder
  5. Uncontrolled hypertension
  6. Head injury within one year
  7. Loss of consciousness >24 hrs
  8. Use of systemic steroid medication (with the exception of Estrogen replacement therapy which is permissible)
  9. Illiterate or unable to read or write English or are judged by the investigator to be unable or unlikely to follow the study protocol
  10. Toxicology evidence of illicit substance use.
Both
55 Years to 90 Years
No
Contact: Timothy Kimball, PhD (650) 493-5000 ext 60482 Timothy.Kimball2@va.gov
United States
 
NCT01120847
SU-06302009-2920
No
Stanford University
Stanford University
Department of Veterans Affairs
Principal Investigator: Jerome A Yesavage Stanford University
Stanford University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP