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Completed

NCT Number: NCT04992676

Comorbid Insomnia and Sleep Disordered Breathing in Patients Undergoing Cardiac Rehabilitation

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Mental Disorders Myocardial Ischemia Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorder; Breathing-Related Sleep Disorder; Insomnia Type Sleep Wake Disorders Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Polysomnograpy

Diagnostic Test

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

Actigraphy

Diagnostic Test

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.

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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

  7. 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

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Sleep Number, Inc.

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 5, 2021
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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