An observational study in Cardiovascular Diseases, sponsored by Mayo Clinic. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-26.
Sponsored by Mayo Clinic · Observational
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 13 is below the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
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Participants eligible for this study will be people who are living in the Masonic Homes/Acacia Creek Retirement Community in Union City, California and who have Sleep Number® beds that record their nightly sleep and physiologic patterns.
Exclusion Criteria:
Mortality
Total number of subject deaths due to medical conditions including congestive heart failure, myocardial infarction, atrial fibrillation and sudden cardiac death.
Time frame: 5 years
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.
Time frame: 5 years
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.
Time frame: Baseline, every 6 months for 5 years
Change in alertness
Measured by alertness rating scale which ranges from 1-6 with lower scores indicating worse subject alertness and function.
Time frame: Baseline, every 6 months for 5 years
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.
Time frame: Baseline, every 6 months for 5 years
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.
Time frame: Baseline, every 6 months for 5 years
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.
Time frame: Baseline, every 6 months for 5 years
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.
Time frame: Baseline, every 6 months for 5 years
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.
Time frame: Baseline, every 6 months for 5 years
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.
Time frame: Baseline, every 6 months for 5 years
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.
Time frame: Baseline, every 6 months for 5 years
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.
Time frame: Baseline, every 6 months for 5 years
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.
Time frame: Baseline, every 6 months for 5 years
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.
Time frame: Baseline, every 6 months for 5 years
Plan to share: No
This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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