Comorbid Insomnia and Sleep Disordered Breathing in Patients Undergoing Cardiac Rehabilitation

NCT ID: NCT04992676

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-19
• Study Completion Date: 2024-05-02

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.

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Polysomnograpy

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

Intervention Type: DIAGNOSTIC_TEST

actigraphy

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sleep Number, Inc.

UNKNOWN

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Amanda R. Bonikowske

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amanda R Bonikowske, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

21-002556

Identifier Type: -

Identifier Source: org_study_id