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

This study is currently recruiting participants.
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
  Purpose

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
Stress Disorders, Post-Traumatic

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: PTSD, Sleep Disordered Breathing And Genetics: Effects On Cognition

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Rey Auditory Verbal Learning Test [ Time Frame: annually ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • APOE status [ Time Frame: sample taken at entry into study. ] [ Designated as safety issue: No ]
    APOE allele


Biospecimen Retention:   Samples With DNA

blood or saliva


Estimated Enrollment: 400
Study Start Date: September 2004
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Veterans with PTSD
No intervention; this is an observational study.
Control group w/out PTSD
No intervention; this is an observational study.

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.

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

US war Veterans with PTSD and possible sleep problems

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120847

Contacts
Contact: Timothy Kimball, PhD (650) 493-5000 ext 60482 Timothy.Kimball2@va.gov

Locations
United States, California
VA Palo Alto Health Care System Recruiting
Palo Alto, California, United States, 94304
Contact: Timothy Kimball, PhD    650-493-5000 ext 60482    Timothy.Kimball2@va.gov   
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Jerome A Yesavage Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01120847     History of Changes
Other Study ID Numbers: SU-06302009-2920
Study First Received: May 7, 2010
Last Updated: December 2, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 22, 2014