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

NCT01120847 | Completed

• 1 other identifier: SU-06302009-2920
• Study Type: observational
• Target: 324
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (1)

• Change in Rey Auditory Verbal Learning Test-Measures auditory learning and memory

  This scale measures auditory learning and memory. The raw score range is 0-15 and scaled score range is 0-19.For raw and scaled scores, higher values represent a better outcome. Subscales are not combined to compute a composite score.

  annually

Secondary Outcomes (1)

• APOE status

  sample taken at entry into study.

Study Arms (2)

Veterans with PTSD

No intervention; this is an observational study.

Control group w/out PTSD

No intervention; this is an observational study.

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

US war Veterans with PTSD and possible sleep problems

You may qualify if:

• 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

You may not qualify if:

• Current or lifetime history of any psychiatric disorder with psychotic features
• Current or lifetime bipolar disorder or delusional disorder
• Prominent suicidal or homicidal ideation
• 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.
• 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

Sponsors & Collaborators

• Stanford University: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood or saliva

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Jerome A Yesavage

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 7, 2010
• First Posted: May 11, 2010
• Study Start: September 1, 2004
• Primary Completion: March 10, 2017
• Study Completion: March 10, 2017
• Last Updated: February 28, 2020

Record last verified: 2020-02

Locations

US (1)