Comorbid Insomnia and Sleep Disordered Breathing in Patients Undergoing Cardiac Rehabilitation

NCT04992676 | Completed

• 1 other identifier: 21-002556
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (9)

• 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

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

coronary artery disease patients participating in cardiac rehab

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Sleep Number, Inc.: collaborator

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

about 7 tablespoons of fasting blood drawn

MeSH Terms

Conditions

Coronary Artery Disease; Sleep Wake Disorders

Interventions

Actigraphy

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Accelerometry; Investigative Techniques

Study Officials

• Amanda R Bonikowske, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 5, 2021
• Study Start: August 19, 2021
• Primary Completion: May 2, 2024
• Study Completion: May 2, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Locations

US (1)