Memory ImpairmentNCT01364753
Age-related Longitudinal Changes in Aviator Performance
An observational study of Memory Impairment, run by Stanford University at 1 site in United States.
Trial summary
Our overall goal has been twofold: 1) to evaluate whether there are significant age-related changes in flight simulator performance near age 60, and 2) to assess whether there is an alternative model that can explain longitudinal flight simulator performance on the basis of measures of cognitive function and expertise. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Memory Impairment
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Dec 2014
- 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 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy older pilots holding active airplane license
Inclusion Criteria:1) licensed aircraft pilot 2) 45 to 70 years of age 3) at least 100 hours of total flight experience 4) current FAA (Federal Aviation Administration) medical certificate of class III or higher
Exclusion Criteria:1) taking psychotropic medications 2) taking other medications with arousal or sedative effects
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
Our overall goal has been twofold: 1) to evaluate whether there are significant age-related changes in flight simulator performance near age 60, and 2) to assess whether there is an alternative model that can explain longitudinal flight simulator performance on the basis of measures of cognitive function and expertise.
Read the detailed description
Our overall goal has been twofold: 1) to evaluate whether there are significant age-related changes in flight simulator performance near age 60, and 2) to assess whether there is an alternative model that can explain longitudinal flight simulator performance on the basis of measures of cognitive function and expertise. Such a model might be able to predict change in aviator performance better than what could be predicted by chronological age alone.
- Conditions
- Memory Impairment
- Keywords
- Memory, Aviation
- Medical subject headings
- Memory Disorders
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 |
|---|---|---|
| Pilots | No intervention; observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aviation-related performance over time.
Participants "fly" in our computerized flight simulator and perform a set of brief tasks designed to measure reaction time and attention span. The study is longitudinal, collecting information about aviation-related performance over time. There is an initial training period, followed by annual visits. During the training period participants learn how to "fly" the simulator, and performance on certain standard maneuvers will be measured during a maximum of 6 simulated flights. At each annual visit, participants fly two 75-minute simulated flights and may be asked to perform up to four holding patterns and instrument landings.
Measured: longitudinal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startJan 2006
- Primary completionJun 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory ImpairmentStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Jerome A Yesavage,, Stanford University
- Investigators
- Jerome A Yesavage, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364753
- Sponsor's protocol ID
- SU-06302009-2940
- Other IDs
- R37AG012713
- Status last verified
- Dec 2016
- First submitted
- 31 May 2011
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-related Longitudinal Changes in Aviator Performance
- ClinicalTrials.gov ID
- NCT01364753
- Acronym / sponsor ID
- SU-06302009-2940
- Conditions
- Memory Impairment
- Keywords
- Memory, Aviation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- Jan 2006
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Jun 2011 (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.
Our overall goal has been twofold: 1) to evaluate whether there are significant age-related changes in flight simulator performance near age 60, and 2) to assess whether there is an alternative model that can explain longitudinal flight simulator performance on the basis of measures of cognitive function and expertise.
Detailed description
Our overall goal has been twofold: 1) to evaluate whether there are significant age-related changes in flight simulator performance near age 60, and 2) to assess whether there is an alternative model that can explain longitudinal flight simulator performance on the basis of measures of cognitive function and expertise. Such a model might be able to predict change in aviator performance better than what could be predicted by chronological age alone.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilots | – | –No intervention; observational study |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy older pilots holding active airplane license
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
Aviation-related performance over time.
Time frame: longitudinal
Participants "fly" in our computerized flight simulator and perform a set of brief tasks designed to measure reaction time and attention span. The study is longitudinal, collecting information about aviation-related performance over time. There is an initial training period, followed by annual visits. During the training period participants learn how to "fly" the simulator, and performance on certain standard maneuvers will be measured during a maximum of 6 simulated flights. At each annual visit, participants fly two 75-minute simulated flights and may be asked to perform up to four holding patterns and instrument landings.
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 6 Dec 2016.
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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 Memory Impairment, 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?
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 6 Dec 2016. 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?
Aviation-related performance over time. (time frame: longitudinal). 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 6 Dec 2016.