Cardiovascular Diseases
Conditions
Keywords
Elderly Patients, Sleep Patterns
Brief summary
The purpose of this study is to learn if there are predictive markers of hospitalization or death that can be found from data gathered from a Sleep Number® bed. This is a prospective observational cohort study that will follow participating subjects in the Masonic Homes/Acacia Creek Retirement Community in Union City, California.
Interventions
None listed
Sponsors
Sleep Number Corporation
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Subjects living at Masonic Homes/Acacia Creek Retirement Community who use a Sleep Number® bed and are cognitively able to consent on their own accord.
Exclusion criteria
* Subjects who do not have a Sleep Number® bed. * Subjects without an internet connection to transmit nightly SleepIQ® data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 5 years | Total number of subject deaths due to medical conditions including congestive heart failure, myocardial infarction, atrial fibrillation and sudden cardiac death. |
| Number of subject hospitalizations | 5 years | Total number of subjects that required hospitalization due to medical conditions including congestive heart failure, myocardial infarction, atrial fibrillation, and sudden cardiac death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in daytime sleepiness | Baseline, every 6 months for 5 years | 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. |
| Change in alertness | Baseline, every 6 months for 5 years | Measured by alertness rating scale which ranges from 1-6 with lower scores indicating worse subject alertness and function. |
| Change in depression symptom severity | Baseline, every 6 months for 5 years | 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. |
| Change in sleep quality | Baseline, every 6 months for 5 years | 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. |
| Change in Attention-deficit/hyperactivity disorder (ADHD) symptom severity | Baseline, every 6 months for 5 years | 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. |
| Change in Verbal Memory | Baseline, every 6 months for 5 years | 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. |
| Change in Visual Memory | Baseline, every 6 months for 5 years | 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. |
| Change in Motor Skills | Baseline, every 6 months for 5 years | 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. |
| Change in Processing Speed | Baseline, every 6 months for 5 years | 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. |
| Change in Stroop Task | Baseline, every 6 months for 5 years | 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. |
| Change in Executive Function | Baseline, every 6 months for 5 years | 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. |
| Change in Vigilance | Baseline, every 6 months for 5 years | 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. |
Countries
United States
Outcome results
None listed