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

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

PTSD, Sleep Disordered Breathing And Genetics: Effects On Cognition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01120847
• Other study ID #: SU-06302009-2920
• Status: Completed
• Start date: September 2004
• Est. completion date: March 10, 2017

Study information

• Verified date: February 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: March 10, 2017
• Est. primary completion date: March 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	APOE status	APOE allele	sample taken at entry into study.