Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Mortality |
Total number of subject deaths due to medical conditions including congestive heart failure, myocardial infarction, atrial fibrillation and sudden cardiac death. |
5 years |
|
| Primary |
Number of subject hospitalizations |
Total number of subjects that required hospitalization due to medical conditions including congestive heart failure, myocardial infarction, atrial fibrillation, and sudden cardiac death. |
5 years |
|
| Secondary |
Change in daytime sleepiness |
Measured by Epworth Sleepiness Scale. The test is a list of eight situations in which you rate your tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. Total score is graded from 0-24. 0-7:It is unlikely that you are abnormally sleepy. 8-9:You have an average amount of daytime sleepiness. 10-15:You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24:You are excessively sleepy and should consider seeking medical attention. |
Baseline, every 6 months for 5 years |
|
| Secondary |
Change in alertness |
Measured by alertness rating scale which ranges from 1-6 with lower scores indicating worse subject alertness and function. |
Baseline, every 6 months for 5 years |
|
| Secondary |
Change in depression symptom severity |
Measured by the Patient Health Questionnaire (PHQ-8) an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity. |
Baseline, every 6 months for 5 years |
|
| Secondary |
Change in sleep quality |
Measured by Pittsburgh Sleep Quality Index. Individuals items within the index are rated on a scale from 0-3 with higher scores indicating worse sleep quality. |
Baseline, every 6 months for 5 years |
|
| Secondary |
Change in Attention-deficit/hyperactivity disorder (ADHD) symptom severity |
Measured by Adult ADHD Self-Report Scale. The ADHD Self-Report Scale consists of 18 items designed to rate ADHD inattention and hyperactivity/impulsivity symptoms. Each item is score from 0 to 4, with a total score ranging from 0 to 72 and higher scores indicating greater symptom severity. |
Baseline, every 6 months for 5 years |
|
| Secondary |
Change in Verbal Memory |
Subjects are tasked with remembering fifteen words, presented one at a time, in a field that contains a total of thirty words (fifteen distractors). Subjects are tested at the beginning of the battery and again near the end. The verbal memory test measures how well subjects can recognize, remember and retrieve words. Low scores indicate verbal memory impairment. |
Baseline, every 6 months for 5 years |
|
| Secondary |
Change in Visual Memory |
Subjects are tasked with remembering fifteen geometric figures, presented one at a time, in a field with fifteen distractors. Subjects are tested near the beginning of the battery and again at the end. The visual memory test measures a subject's ability to recognize, remember and retrieve shapes. Low scores indicate visual memory impairment. |
Baseline, every 6 months for 5 years |
|
| Secondary |
Change in Motor Skills |
Measured by the Finger Tapping Test (FTT). The FTT tests motor speed and fine motor control. In it, subjects participate in three rounds of tapping with each hand; lowering scores indicate motor slowing. |
Baseline, every 6 months for 5 years |
|
| Secondary |
Change in Processing Speed |
Measured by Symbol Digit Coding which draws upon several cognitive processes simultaneously (such as visual scanning, visual perception, visual memory and motor function). Subjects are presented with a simple grid, with numbers corresponding to a particular symbol. Sequences of symbols are then provided, which the subject must render in numerics. Low scores are indicative of slow processing speed, possibly due to cognitive impairment. |
Baseline, every 6 months for 5 years |
|
| Secondary |
Change in Stroop Task |
The Stroop Task measures how well subjects adapt to rapidly changing (and increasingly complex) sets of directions. Words for various colors (i.e. RED, GREEN) are presented in various font colors, which may or may not correspond (i.e. the word "RED" may be rendered in red, or in green). Subjects are tasked with responding under various conditions, such as when the word is rendered in the corresponding color, or when the word and the color it is rendered in are mismatched. Prolonged reactions times indicate cognitive slowing/impairment. |
Baseline, every 6 months for 5 years |
|
| Secondary |
Change in Executive Function |
Measured by the Shifting Attention Test (SAT). The SAT measures executive function; specifically, how well a subject recognizes set shifting (mental flexibility) and abstraction (rules, categories), and manages multiple tasks simultaneously. In addition, subjects have to adjust their responses to randomly changing rule sets. Low scores are most indicative of cognitive impairments. |
Baseline, every 6 months for 5 years |
|
| Secondary |
Change in Vigilance |
Measured by the Continuous Performance Test (CPT). The CPT measures sustained vigilance and choice reaction time. Two errors may be clinically significant, more than four errors is clinically significant and likely indicates attentional dysfunction. |
Baseline, every 6 months for 5 years |
|
