Post Traumatic Stress Disorder/ptsd |
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Clinical Trial: Post-traumatic Stress Disorder (PTSD), Sleep Apnea, Apolipoprotein E (APOE), and Cognition
This study is currently recruiting patients.
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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 |
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| 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
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
- 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.
- 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)
- Unstable or severe cardiovascular disease
- Unstable gastrointestinal disorder
- Uncontrolled hypertension
- Head injury within one year
- Loss of consciousness >24 hrs
- Use of CNS active medications or use of systemic steroid medication (with the exception of estrogen replacement therapy which is permissible)
- Illiterate or unable to read or write English or are judged by the investigator to be unable or unlikely to follow the study protocol
- Toxicology evidence of illicit substance use
Location and Contact Information
California
VA Medical Center, Palo Alto, California, 94304, United States; Recruiting
Jerome Yesavage, M.D., Principal Investigator
More Information
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
Resources
- Accommodations For People with PTSD (Job Accommodation Network)
- Anxiety Disorders (National Mental Health Information Center, SAMHSA, HHS)

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