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A Study of Sleep Patterns to Determine Predictive Markers Due to Cardiovascular Disease in Elderly Patients
Sleep Patterns as Predictive Markers of Hospitalization or Death Due to Cardiovascular Disease in Elderly Patients
1 other identifier
observational
13
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2023
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2023
CompletedFirst Posted
Study publicly available on registry
March 1, 2023
CompletedStudy Start
First participant enrolled
May 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedAugust 26, 2024
May 1, 2024
10 months
February 16, 2023
August 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mortality
Total number of subject deaths due to medical conditions including congestive heart failure, myocardial infarction, atrial fibrillation and sudden cardiac death.
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.
5 years
Secondary Outcomes (12)
Change in daytime sleepiness
Baseline, every 6 months for 5 years
Change in alertness
Baseline, every 6 months for 5 years
Change in depression symptom severity
Baseline, every 6 months for 5 years
Change in sleep quality
Baseline, every 6 months for 5 years
Change in Attention-deficit/hyperactivity disorder (ADHD) symptom severity
Baseline, every 6 months for 5 years
- +7 more secondary outcomes
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Subjects who do not have a Sleep Number® bed.
- Subjects without an internet connection to transmit nightly SleepIQ® data.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Sleep Number Corporationcollaborator
Study Sites (2)
Masonic Homes of California-Acacia Creek
Union City, California, 94587, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Amir Lerman, M.D.
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 16, 2023
First Posted
March 1, 2023
Study Start
May 23, 2023
Primary Completion
April 1, 2024
Study Completion
April 1, 2024
Last Updated
August 26, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share