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

Brief Summary:

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.

Condition or disease
Stress Disorders, Post-Traumatic

Detailed Description:

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.

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: PTSD, Sleep Disordered Breathing And Genetics: Effects On Cognition
Study Start Date : September 2004
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Veterans with PTSD
No intervention; this is an observational study.
Control group w/out PTSD
No intervention; this is an observational study.

Primary Outcome Measures :
  1. Rey Auditory Verbal Learning Test [ Time Frame: annually ]

Secondary Outcome Measures :
  1. APOE status [ Time Frame: sample taken at entry into study. ]
    APOE allele

Biospecimen Retention:   Samples With DNA
blood or saliva

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
US war Veterans with PTSD and possible sleep problems

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01120847

United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
VA Office of Research and Development
Principal Investigator: Jerome A Yesavage Stanford University

Responsible Party: Jerome A Yesavage,, Professor, Stanford University Identifier: NCT01120847     History of Changes
Other Study ID Numbers: SU-06302009-2920
First Posted: May 11, 2010    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: December 2016

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders