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

PTSD, Sleep Disordered Breathing And Genetics: Effects On Cognition

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.

Study Overview

• Status: Completed
• Conditions: Stress Disorders, Post-Traumatic

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.

• Study Type: Observational
• Enrollment (Actual): 324

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • VA Palo Alto Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

US war Veterans with PTSD and possible sleep problems

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Veterans with PTSD; No intervention; this is an observational study.
Control group w/out PTSD; No intervention; this is an observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
APOE status	APOE allele	sample taken at entry into study.

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: US Department of Veterans Affairs

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2004
• Primary Completion (Actual): March 10, 2017
• Study Completion (Actual): March 10, 2017

Study Registration Dates

• First Submitted: May 7, 2010
• First Submitted That Met QC Criteria: May 10, 2010
• First Posted (Estimate): May 11, 2010

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 26, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Trauma and Stressor Related Disorders; Sleep Apnea Syndromes; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: SU-06302009-2920