Comorbid Insomnia and Sleep Disordered Breathing in Patients Undergoing Cardiac Rehabilitation

Mayo Clinic43 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Coronary Artery Disease Sleep Disorder; Breathing-Related Sleep Disorder; Insomnia Type

Interventions

PolysomnograpyDIAGNOSTIC_TEST

Home polysomnography will be conducted using the scalable, modular Embletta system. Trained staff will instrument the participants in the evening and perform biocalibration to ensure optimal data quality

actigraphyDIAGNOSTIC_TEST

A water resistant accelerometer with light sensor and event marker will be worn on the nondominant wrist for approximately 7 days. Activity counts from the device will be analyzed by proprietary software algorithms for determination of the following: sleep onset, sleep offset, total sleep time, total wake time, and sleep efficiency.16 Daytime sleep periods will be also scored to determine frequency and duration of naps. Daily data will be averaged across the 7-day period, as well as separately for weekdays and weekend, to compute measures of habitual sleep patterns.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

To examine the prevalence of comorbid sleep disordered breathing and insomnia in post-MI patients enrolled in cardiac rehab.

Comorbid SDB and insomnia will be highly prevalent (\>30%) in this population. Measured by home, overnight polysomnography

Time frame: 6 months

The combination of both sleep disorders will be associated with more detrimental CV risk markers (cardiorespiratory fitness) than either sleep disorder alone.

To assess whether post-MI CR patients with comorbid SDB and insomnia exhibit a more unfavorable CV profile than those without.

Time frame: 6 months

The combination of both sleep disorders will be associated with more detrimental CV risk markers (blood pressure) than either sleep disorder alone

To assess whether post-MI CR patients with comorbid SDB and insomnia exhibit a more unfavorable CV profile than those without.

Time frame: 6 months

The combination of both sleep disorders will be associated with more detrimental CV risk markers (lipids) than either sleep disorder alone

To assess whether post-MI CR patients with comorbid SDB and insomnia exhibit a more unfavorable CV profile than those without.

Time frame: 6 months

The combination of both sleep disorders will be associated with more detrimental CV risk markers (depression) than either sleep disorder alone

To assess whether post-MI CR patients with comorbid SDB and insomnia exhibit a more unfavorable CV profile than those without using the PHQ-9.

Time frame: 6 months

The combination of both sleep disorders will be associated with lower adherence to CR - number of attended sessions

To determine whether post-MI CR patients with comorbid SDB and insomnia show less adherence to CR attendance than those without

Data from ClinicalTrials.gov

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