Sleep Quality and Sleep-disordered Breathing in Bypass Surgery Patients

Recruiting

• Conditions: Coronary Artery Disease; Sleep Disorder

• Registration Number: NCT06453538
• Lead Sponsor: Turku University Hospital

Brief Summary

Patients undergoing non-emergency coronary artery bypass surgery (CABG) are included. All patients will be examined for transthoracic echo, blood samples will be collected, and an overnight sleep polygraph will be performed in a qualified sleep laboratory twice: once before CABG and again after surgery

Detailed Description

Detailed Description:

Our hypothesis is that sleep-related apneas are increasing following coronary artery bypass surgery, and sleep quality may deteriorate. We are attempting to determine the causes of these difficulties, which are caused by microemboli in the brain from the use of a heart-lung machine, brain infarction induced by major surgery, thoracic tissue trauma following surgery, or complications during perioperative care. The hypothesis is that postoperative outcomes and recovery are related if a patient is identified with sleep apnea before CABG surgery. A sleep polygraph is performed before surgery and again around six months after, as well as a transthoracic echo and laboratory tests. If a link between sleep quality and coronary bypass surgery can be established, the results can be employed in clinical practice.

The total amount of patients operated on heart-lung machine is anticipated to be 70. The off-pump patient sample size is remarkably smaller, so data is collected and compared with the main sample population. The operation technique is decided when the patient is scheduled for operation. Emergency patients are excluded because pre-operative examinations cannot be performed. Other exclusion criteria are nighttime CPAP- treatment and other heart operations (for example valve surgery) during CABG.

Basic information including age, weight, height, diseases, medications, and medical history are collected from all patients. ECG is registered before and after surgery and sinus or other heart rhythms are recorded. Sleep polygraph is done preoperatively and postoperatively when the patient is fully recovered from surgery (at 6 months or more).

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2024-04-10
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-04
• Study First Posted: 2024-06-11
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-26
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Elective coronary artery bypass surgery

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Exclusion Criteria

• Emergency cabg
• Night time cpap- treatment
• other heart operations (for example valve surgery)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of sleep disorders before coronary artery bypass surgery (CABG), polysomnography	Before operation, as soon as operation has scheduled	Apnea-hypopnea index (AHI). Number of apneas and hypopneas that occur per hour of sleep. According to the American Academy of Sleep Medicine (AASM) it is categorized into mild (5-15 events/hour), moderate (15-30 events/hr), and severe (\> 30 events/hr) (1).
Sleep quality before CABG	Before operation, as soon as operation has scheduled	ESS, EPWORTH SLEEPINESS SCALE. All scores on the Epworth Sleepiness Scale fall between 0 and 24. Scores from 0 to 10 reflect normal levels of daytime sleepiness, and scores over 10 are considered to reflect excessive daytime sleepiness.
A transthoracic echocardiogram	Before operation, as soon as operation has scheduled	Left ventricular end-diastolic diameter (LVEDD), Left ventricular end-systolic diameter (LVESD), Septal wall thickness (SWT), and Posterior wall thickness (PWT), Max/Min Diameter of IVC; all will be reported in cm.

Secondary Outcome Measures

Name	Time	Method
Sleep quality after CABG	After 6 to 8 months after surgery	ESS, EPWORTH SLEEPINESS SCALE. All scores on the Epworth Sleepiness Scale fall between 0 and 24. Scores from 0 to 10 reflect normal levels of daytime sleepiness, and scores over 10 are considered to reflect excessive daytime sleepiness
A transthoracic echocardiogram	After operation, 3-5 months after surgery	Left ventricular end-diastolic diameter (LVEDD), Left ventricular end-systolic diameter (LVESD), Septal wall thickness (SWT), and Posterior wall thickness (PWT), Max/Min Diameter of IVC; all will be reported in cm.
Incidence of sleep disorders after coronary artery bypass surgery, polysomnography	After 6 to 8 months after surgery	Apnea-hypopnea index (AHI). Number of apneas and hypopneas that occur per hour of sleep. According to the American Academy of Sleep Medicine (AASM) it is categorized into mild (5-15 events/hour), moderate (15-30 events/hr), and severe (\> 30 events/hr) (1).

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland