Comorbid Insomnia and Sleep Disordered Breathing in Patients Undergoing Cardiac Rehabilitation

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04992676
• Other study ID #: 21-002556
• Status: Active, not recruiting
• Start date: August 19, 2021
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Parasomnias
• Respiratory Aspiration
• Sleep Apnea Syndromes
• Sleep Disorder; Breathing-Related
• Sleep Disorder; Insomnia Type
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders

Intervention

Diagnostic Test:
• 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
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Sleep Number, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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