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Post-traumatic Stress Disorder (PTSD), Sleep Apnea, Apolipoprotein E (APOE), and Cognition - Article


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Post Traumatic Stress Disorder/ptsd

 




Clinical Trial: Post-traumatic Stress Disorder (PTSD), Sleep Apnea, Apolipoprotein E (APOE), and Cognition

This study is currently recruiting patients.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs

Purpose

The purpose of this study is to examine whether sleep-disordered breathing, APOE status, increasing age and their interactions will predict rate of cognitive decline in veterans who have PTSD, a population already at risk for cognitive deficits.

Condition
Post-Traumatic Stress Disorder
Sleep Apnea

MedlinePlus related topics:  Post-Traumatic Stress Disorder;   Sleep Apnea

Study Type: Observational
Study Design: Psychosocial, Longitudinal, Defined Population, Prospective Study

Official Title: PTSD, Sleep Disordered Breathing and APOE Genotype: Effects on Cognition

Further Study Details: 

Expected Total Enrollment:  130

Study start: January 2005;  Expected completion: December 2009

This study will examine whether sleep-disordered breathing, APOE status, increasing age and their interactions will predict rate of cognitive decline in veterans who have PTSD, a population already at risk for cognitive deficits. A longitudinal design will be employed. Longitudinal analyses will be performed using a random regression model. The study will be conducted at the VA Palo Alto Health Care System (VAPAHCS). The investigators have complementary expertise, and a track record of federally supported research in the areas of PTSD, sleep disorders, aging, and measurement of cognition. Our primary and secondary hypotheses will be tested in a sample of 130 PTSD subjects who will be assessed longitudinally. The primary cognitive outcome measure, the Rey Auditory Verbal Learning Test (RAVLT), will be assessed at baseline and annually for a total of four years. Possible moderators and mediators of response, primarily APOE status and sleep-disordered breathing will also be collected. APOE status measures will be collected at baseline only and sleep-disordered breathing measures will be collected annually.

Eligibility

Ages Eligible for Study:  55 Years and above,  Genders Eligible for Study:  Male

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • Age 55 years or older, male or female veterans of any racial or ethnic group.
  • 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
  • Capable of giving informed consent for the study
  • Sufficient visual and auditory acuity for cognitive testing

Exclusion Criteria:

Psychiatric Exclusions

  • Current or lifetime history of any psychiatric disorder with psychotic features
  • Current or lifetime bipolar disorder or delusional disorder
  • Prominent suicidal or homicidal ideation
  • Use of antipsychotic medications during the past 3 months
  • Current exposure to trauma or recent exposure to trauma in the past 3 months.
  • Currently or have within the past six months met DSM-IV criteria for drug or alcohol abuse or dependence (except nicotine).
  • Presence of alcohol intoxication (by breathalyzer) or alcohol withdrawal (by exam) during testing
  • Diagnosis of probable or possible dementia
  • Mini-Mental State Exam (MMSE) < 23
  • History of seizure disorder.
  • Require treatment with any prescription or over the counter drug known to have a psychotropic activity, or known to influence sleep behavior.

Medical/Medication Exclusions


Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00108641


California
      VA Medical Center, Palo Alto,  California,  94304,  United States; Recruiting
Jerome Yesavage, M.D.  650-852-3287    yesavage@stanford.edu 
Jerome Yesavage, M.D.,  Principal Investigator

More Information

Study ID Numbers:  YES0048
Record last reviewed:  April 2005
Last Updated:  April 15, 2005
Record first received:  April 15, 2005
ClinicalTrials.gov Identifier:  NCT00108641
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-05-03


Source: ClinicalTrials.gov
Cache Date: May 4, 2005

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November 25, 2009



Page Updated: September 6, 2005
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