Comorbid Insomnia and Sleep Disordered Breathing in Patients Undergoing Cardiac Rehabilitation

Completed

• Conditions: Sleep Disorder; Breathing-Related; Sleep Disorder; Insomnia Type; Coronary Artery Disease

• Registration Number: NCT04992676
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-07-29
• Study First Posted: 2021-08-05
• Study Start: 2021-08-19
• Primary Completion: 2024-05-02
• Study Completion: 2024-05-02
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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).

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The combination of both sleep disorders will be associated with more detrimental CV risk markers (lipids) than either sleep disorder alone	6 months	To assess whether post-MI CR patients with comorbid SDB and insomnia exhibit a more unfavorable CV profile than those without.
The combination of both sleep disorders will be associated with lower adherence to CR - exercise	6 months	To determine whether post-MI CR patients with comorbid SDB and insomnia show less adherence to the exercise prescription than those without
The combination of both sleep disorders will be associated with lower adherence to CR - number of attended sessions	6 months	To determine whether post-MI CR patients with comorbid SDB and insomnia show less adherence to CR attendance than those without
The combination of both sleep disorders will be associated with more detrimental CV risk markers (blood pressure) than either sleep disorder alone	6 months	To assess whether post-MI CR patients with comorbid SDB and insomnia exhibit a more unfavorable CV profile than those without.
The combination of both sleep disorders will be associated with more detrimental CV risk markers (cardiorespiratory fitness) than either sleep disorder alone.	6 months	To assess whether post-MI CR patients with comorbid SDB and insomnia exhibit a more unfavorable CV profile than those without.
The combination of both sleep disorders will be associated with lower adherence to CR - dietary prescription	6 months	To determine whether post-MI CR patients with comorbid SDB and insomnia show less adherence to dietary recommendations than those without
To examine the prevalence of comorbid sleep disordered breathing and insomnia in post-MI patients enrolled in cardiac rehab.	6 months	Comorbid SDB and insomnia will be highly prevalent (\>30%) in this population. Measured by home, overnight polysomnography
The combination of both sleep disorders will be associated with more detrimental CV risk markers (depression) than either sleep disorder alone	6 months	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.
The combination of both sleep disorders will be associated with lower adherence to CR - adherence to pharmacotherapy	6 months	To determine whether post-MI CR patients with comorbid SDB and insomnia show less adherence to prescribed medications than those without

Trial Locations

Locations (1)

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States