Comorbid Insomnia and Sleep Disordered Breathing in Patients Undergoing Cardiac Rehabilitation

  • End date
    Sep 15, 2023
  • participants needed
  • sponsor
    Mayo Clinic
Updated on 15 November 2021
myocardial infarction
unstable angina
percutaneous coronary intervention
cardiac rehabilitation
acute coronary syndrome
bypass surgery


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.

Condition Coronary heart disease, Myocardial Ischemia, Sleep Disorder; Insomnia Type, Coronary Artery Disease, Sleep Disorder; Breathing-Related, Cardiac Ischemia
Treatment Actigraphy, Polysomnograpy
Clinical Study IdentifierNCT04992676
SponsorMayo Clinic
Last Modified on15 November 2021


Yes No Not Sure

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 STelevation 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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