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.
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
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.
- Conditions
- Cardiovascular Diseases
- 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.
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
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)
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted1 Mar 2023
- Study start23 May 2023
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Why it stopped: Difficulty managing the study from a different state
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Sleep Number Corporation
- Responsible party
- Principal investigator, Amir Lerman, Mayo Clinic
- Investigators
- Amir Lerman, M.D., Principal investigator, Mayo Clinic
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Patterns as Predictive Markers of Hospitalization or Death Due to Cardiovascular Disease in Elderly Patients
- ClinicalTrials.gov ID
- NCT05749263
- Acronym / sponsor ID
- 22-001110
- Conditions
- Cardiovascular Diseases
- Keywords
- Elderly Patients, Sleep Patterns
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty managing the study from a different state
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Sleep Number Corporation
- Study start
- 23 May 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 1 Mar 2023 (actual)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Subjects who do not have a Sleep Number® bed.
- Subjects without an internet connection to transmit nightly SleepIQ® data.
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
Mortality
Time frame: 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
Time frame: 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.
12 secondary outcomes
Change in daytime sleepiness
Time frame: Baseline, every 6 months for 5 years
Change in alertness
Time frame: Baseline, every 6 months for 5 years
Change in depression symptom severity
Time frame: Baseline, every 6 months for 5 years
Change in sleep quality
Time frame: Baseline, every 6 months for 5 years
Change in Attention-deficit/hyperactivity disorder (ADHD) symptom severity
Time frame: Baseline, every 6 months for 5 years
Change in Verbal Memory
Time frame: Baseline, every 6 months for 5 years
Change in Visual Memory
Time frame: Baseline, every 6 months for 5 years
Change in Motor Skills
Time frame: Baseline, every 6 months for 5 years
Change in Processing Speed
Time frame: Baseline, every 6 months for 5 years
Change in Stroop Task
Time frame: Baseline, every 6 months for 5 years
Change in Executive Function
Time frame: Baseline, every 6 months for 5 years
Change in Vigilance
Time frame: Baseline, every 6 months for 5 years
Results and safety
The study was stopped early (reason given: Difficulty managing the study from a different state). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Amir Lerman, M.D. principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
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.