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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01120847
Recruitment Status : Active, not recruiting
First Posted : May 11, 2010
Last Update Posted : February 10, 2017
VA Office of Research and Development
Information provided by (Responsible Party):
Jerome A Yesavage,, Stanford University

May 7, 2010
May 11, 2010
February 10, 2017
September 2004
December 2017   (Final data collection date for primary outcome measure)
Rey Auditory Verbal Learning Test [ Time Frame: annually ]
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Complete list of historical versions of study NCT01120847 on Archive Site
APOE status [ Time Frame: sample taken at entry into study. ]
APOE allele
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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 Model: Case-Control
Time Perspective: Prospective
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Retention:   Samples With DNA
blood or saliva
Non-Probability Sample
US war Veterans with PTSD and possible sleep problems
Stress Disorders, Post-Traumatic
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  • Veterans with PTSD
    No intervention; this is an observational study.
  • Control group w/out PTSD
    No intervention; this is an observational study.
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
December 2017
December 2017   (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.
Sexes Eligible for Study: All
55 Years to 90 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Jerome A Yesavage,, Stanford University
Stanford University
VA Office of Research and Development
Principal Investigator: Jerome A Yesavage Stanford University
Stanford University
December 2016