Post Traumatic Stress Disorder (PTSD), Sleep Disordered Breathing And Genetics: Effects On Cognition
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Stanford University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Stanford University
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01120847
First received: May 7, 2010
Last updated: May 10, 2010
Last verified: May 2010
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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 | Intervention |
|---|---|
|
Stress Disorders, Post-Traumatic |
Behavioral: observational testing |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort 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:
Biospecimen Retention: Samples With DNA
Detailed Description:
blood or saliva
| Estimated Enrollment: | 150 |
| Study Start Date: | September 2004 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
The research project will clarify how sleep disordered breathing and 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:
- 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
Exclusion Criteria:
Psychiatric Exclusions:
- 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
- MMSE < 23
- History of seizure disorder.
Medical/Medication Exclusions:
- 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 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
- Loss of consciousness >24 hrs
- Use of systemic steroid medication (with the exception of Estrogen replacement therapy which is permissible)
- Illiterate or unable to read or write English or are judged by the investigator to be unable or unlikely to follow the study protocol
- 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: | Jerome A Yesavage, Stanford University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01120847 History of Changes |
| Other Study ID Numbers: | SU-06302009-2920, 243 |
| Study First Received: | May 7, 2010 |
| Last Updated: | May 10, 2010 |
| 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 May 16, 2013