Stress Disorders, Post-TraumaticNCT01120847
Post Traumatic Stress Disorder (PTSD), Sleep Disordered Breathing And Genetics: Effects On Cognition
An observational study of Stress Disorders, Post-Traumatic, run by Stanford University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- How many people
- 324 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to 10 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: US war Veterans with PTSD and possible sleep problems
Who may be able to join
- 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
Who cannot join
- 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).
Show all 21Show fewer
- 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.
- 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 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
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94304
About this study
Official title: 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.
Read the 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
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Veterans with PTSD | No intervention; this is an observational study. | |
| Control group w/out PTSD | No intervention; this is an observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: annually
Secondary outcomes (1)
APOE status
APOE allele
Measured: sample taken at entry into study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study startSep 2004
- Primary completion10 Mar 2017
- Study completion10 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Principal investigator, Jerome A Yesavage,, Stanford University
- Investigators
- Jerome A Yesavage, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120847
- Sponsor's protocol ID
- SU-06302009-2920
- Status last verified
- Feb 2020
- First submitted
- 7 May 2010
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PTSD, Sleep Disordered Breathing And Genetics: Effects On Cognition
- ClinicalTrials.gov ID
- NCT01120847
- Acronym / sponsor ID
- SU-06302009-2920
- Conditions
- Stress Disorders, Post-Traumatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- Sep 2004 (actual)
- Primary completion
- 10 Mar 2017 (actual)
- Study completion
- 10 Mar 2017 (actual)
- First posted
- 11 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Veterans with PTSD | – | –No intervention; this is an observational study. |
| Control group w/out PTSD | – | –No intervention; this is an observational study. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- US war Veterans with PTSD and possible sleep problems
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (21 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Rey Auditory Verbal Learning Test-Measures auditory learning and memory
Time frame: annually
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.
1 secondary outcome
APOE status
Time frame: sample taken at entry into study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
Related trials for Stress Disorders, Post-Traumatic
Active, not recruiting
TMS-fNIRS Personalized Dosing
Post Traumatic Stress Disorder, Traumatic Brain Injury
Enrolling by invitation
Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury
Spinal Cord Injuries, PTSD
Not yet recruitingObservational study
The Effects of Extreme Prematurity on Parenting
Depression Disorder, Post Traumatic Stress Disorder PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Not yet recruiting
Feasibility of a Web-based Single-session Intervention Combined With Ecological Momentary Assessment and Intervention for Patients With Complex Posttraumatic Stress Disorder Awaiting Inpatient Treatment
PTSD - Post Traumatic Stress Disorder, Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerome A Yesavage principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Disorders, Post-Traumatic, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Rey Auditory Verbal Learning Test-Measures auditory learning and memory (time frame: annually). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.