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

NCT ID: NCT01120847

Last Updated: 2020-02-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 324 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2017-03-10

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.

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.

Conditions

Stress Disorders, Post-Traumatic

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Veterans with PTSD

No intervention; this is an observational study.

No interventions assigned to this group

Control group w/out PTSD

No intervention; this is an observational study.

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Jerome A Yesavage,

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jerome A Yesavage

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

VA Palo Alto Health Care System

Palo Alto, California, United States

Countries

United States

Other Identifiers

SU-06302009-2920

Identifier Type: -

Identifier Source: org_study_id