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Comorbid Insomnia and Sleep Disordered Breathing in Patients Undergoing Cardiac Rehabilitation

Comorbid Insomnia and Sleep Disordered Breathing in Patients Undergoing Cardiac Rehabilitation

Non Recruiting
18-99 years
All
Phase N/A

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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.

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

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.

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

NCT04992676

Mayo Clinic

20 August 2025

FAQs

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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