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Cardiovascular DiseasesNCT05749263

A Study of Sleep Patterns to Determine Predictive Markers Due to Cardiovascular Disease in Elderly Patients

An observational study of Cardiovascular Diseases, run by Mayo Clinic at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiovascular Diseases
How many people
13 participants
Where
2 sitesUnited States
Study dates
23 May 2023to 1 Apr 2024
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 18 years and older
  • All sexes
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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.

Who cannot join

  • Subjects who do not have a Sleep Number® bed.
  • Subjects without an internet connection to transmit nightly SleepIQ® data.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Masonic Homes of California-Acacia Creek

    Union City, California, 94587

Other trials in United States

About this study

Official title: Sleep Patterns as Predictive Markers of Hospitalization or Death Due to Cardiovascular Disease in Elderly Patients

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.

Keywords
Elderly Patients, Sleep Patterns
Medical subject headings
Cardiovascular Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    Total number of subject deaths due to medical conditions including congestive heart failure, myocardial infarction, atrial fibrillation and sudden cardiac death.

    Measured: 5 years

  2. 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.

    Measured: 5 years

Secondary outcomes (12)
  1. 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.

    Measured: Baseline, every 6 months for 5 years

  2. Change in alertness

    Measured by alertness rating scale which ranges from 1-6 with lower scores indicating worse subject alertness and function.

    Measured: Baseline, every 6 months for 5 years

  3. 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.

    Measured: Baseline, every 6 months for 5 years

  4. 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.

    Measured: Baseline, every 6 months for 5 years

  5. 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.

    Measured: Baseline, every 6 months for 5 years

  6. 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.

    Measured: Baseline, every 6 months for 5 years

  7. 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.

    Measured: Baseline, every 6 months for 5 years

  8. 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.

    Measured: Baseline, every 6 months for 5 years

  9. 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.

    Measured: Baseline, every 6 months for 5 years

  10. 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.

    Measured: Baseline, every 6 months for 5 years

  11. 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.

    Measured: Baseline, every 6 months for 5 years

  12. 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.

    Measured: Baseline, every 6 months for 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2023
  2. Study start23 May 2023
  3. Primary completion1 Apr 2024
  4. Study completion1 Apr 2024

Why it stopped: Difficulty managing the study from a different state

Resources

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
Cohort
Time perspective
Prospective
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05749263
Sponsor's protocol ID
22-001110
Status last verified
May 2024
First submitted
16 Feb 2023
Last updated
26 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases, run by Mayo Clinic at 2 sites 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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 was stopped early (reason given: Difficulty managing the study from a different state). Results are not available in the source record.

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?

Mortality (time frame: 5 years). The study lists 2 primary outcomes in all. 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 26 Aug 2024; AzTrials last refreshed its copy on 30 Oct 2026.

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