Clinical trial NCT04992676: Comorbid Insomnia and Sleep Disordered Breathing in Patients Undergoing Cardiac Rehabilitation
Official title: Comorbid Insomnia and Sleep Disordered Breathing in Patients Undergoing Cardiac Rehabilitation: Prevalence and Impact on Cardiovascular Risk Profile
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Sleep Disorder; Breathing-Related
Sleep Disorder; Insomnia Type
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Sleep Number, Inc.
First posted: 2021-08-05
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: coronary artery disease patients participating in cardiac rehab

Brief summary: The purpose of this research is to determine how frequently sleep disorders such as sleep disordered breathing and insomnia occur in patients with coronary artery disease enrolled in cardiac rehabilitation. By reviewing results of a variety of tests, we also hope to learn more about the cardiovascular effects on people who may have these conditions.

Detailed description: Patients referred to the Mayo Clinic Rochester CR and meeting eligibility criteria (see Subjects section below) will be recruited and consented. Prior to beginning CR, enrolled patients will undergo baseline sleep and CV assessment at the Clinical Research and Trials Unit (CRTU). Home-based sleep monitoring will take place. Patients will also complete additional cardiometabolic and behavioral evaluation as part of the standard CR clinical care. Following completion of the 12-week CR program, a post-CR assessment may be conducted, including the same set of tests/procedures. All patients will be followed up for at least 6-months following enrollment to monitor cardiac recurrence, hospitalization and death.

Eligibility criteria: Inclusion Criteria:

* Patients will be \>18 years old
* Referred to CR following admitted to the hospital with a documented diagnosis of acute coronary syndrome
* Referred to CR following admission to the hospital with a documented diagnosis of ST- elevation myocardial infarction (STEMI),
* Referred to CR following admission to the hospital with a documented diagnosis of non- STEMI
* Referred to CR following admission to the hospital with a documented diagnosis of unstable angina
* Referred to CR following admission to the hospital with a documented diagnosis of post coronary artery bypass surgery
* Referred to CR following admission to the hospital after percutaneous coronary intervention (with or without stent placement).

Exclusion Criteria:

* heart failure with reduced ejection fraction
* peripheral artery disease
* valve or pericardial surgery
* heart transplantation
* patients unable to provide informed consent
* patients unable to speak and read English
* night shift workers
* pregnant women
* those who will only attend full home-based CR.

Primary outcomes:
measure: To examine the prevalence of comorbid sleep disordered breathing and insomnia in post-MI patients enrolled in cardiac rehab.
timeFrame: 6 months
measure: The combination of both sleep disorders will be associated with more detrimental CV risk markers (cardiorespiratory fitness) than either sleep disorder alone.
timeFrame: 6 months
measure: The combination of both sleep disorders will be associated with more detrimental CV risk markers (blood pressure) than either sleep disorder alone
timeFrame: 6 months
measure: The combination of both sleep disorders will be associated with more detrimental CV risk markers (lipids) than either sleep disorder alone
timeFrame: 6 months
measure: The combination of both sleep disorders will be associated with more detrimental CV risk markers (depression) than either sleep disorder alone
timeFrame: 6 months
measure: The combination of both sleep disorders will be associated with lower adherence to CR - number of attended sessions
timeFrame: 6 months
measure: The combination of both sleep disorders will be associated with lower adherence to CR - adherence to pharmacotherapy
timeFrame: 6 months
measure: The combination of both sleep disorders will be associated with lower adherence to CR - exercise
timeFrame: 6 months
measure: The combination of both sleep disorders will be associated with lower adherence to CR - dietary prescription
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Amanda R Bonikowske, PhD
role: PRINCIPAL_INVESTIGATOR
References: