Comorbid Insomnia and Sleep Disordered Breathing in Patients Undergoing Cardiac Rehabilitation

July 16, 2024 updated by: Amanda R. Bonikowske, Mayo Clinic

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 6 months
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.
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 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.
6 months
The combination of both sleep disorders will be associated with lower adherence to CR - number of attended sessions
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sleep Number, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amanda R Bonikowske, PhD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 19, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 2, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 2, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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