Comorbid Insomnia and Sleep Disordered Breathing in Patients Undergoing Cardiac Rehabilitation

Comorbid Insomnia and Sleep Disordered Breathing in Patients Undergoing Cardiac Rehabilitation: Prevalence and Impact on Cardiovascular Risk Profile

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Sleep Disorder; Breathing-Related; Sleep Disorder; Insomnia Type
• Intervention / Treatment: Diagnostic test: Polysomnograpy; Diagnostic test: actigraphy

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.

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

coronary artery disease patients participating in cardiac rehab

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	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.	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	6 months
The combination of both sleep disorders will be associated with lower adherence to CR - adherence to pharmacotherapy	To determine whether post-MI CR patients with comorbid SDB and insomnia show less adherence to prescribed medications than those without	6 months
The combination of both sleep disorders will be associated with lower adherence to CR - exercise	To determine whether post-MI CR patients with comorbid SDB and insomnia show less adherence to the exercise prescription than those without	6 months
The combination of both sleep disorders will be associated with lower adherence to CR - dietary prescription	To determine whether post-MI CR patients with comorbid SDB and insomnia show less adherence to dietary recommendations than those without	6 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Sleep Number, Inc.
• Investigators: Principal Investigator: Amanda R Bonikowske, PhD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2021
• Primary Completion (Actual): May 2, 2024
• Study Completion (Actual): May 2, 2024

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Coronary Disease; Coronary Artery Disease; Sleep Apnea Syndromes; Sleep Wake Disorders; Respiratory Aspiration; Sleep Initiation and Maintenance Disorders; Parasomnias
• Other Study ID Numbers: 21-002556

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No