Sleep Quality and Sleep-disordered Breathing in Bypass Surgery Patients

Coronary Artery Disease Clinical Trial

— UNI-CABG  

Official title:

Sleep Quality and Sleep-disordered Breathing in Bypass Surgery Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06453538
• Other study ID #: 27 /1801/2022
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: June 2024
• Source: Turku University Hospital
• Contact: Marjo Ajosenpää, MD
• Phone: +35823133247
• Email: marjo.ajosenpaa[@]varha.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To this study is recruiting non- emergency patients to whom are planning to make coronary artery bypass intervention. From all patients are going to examine transthoracic echo, collect blood samples and register overnight sleep polygraph in a qualified sleep laboratory two times; first before cabg and second one after surgery.

Description:

Detailed Description:

Hypothesis, that sleep related apneas are increasing after coronary artery bypass surgery and sleep quality may deteriorate. We are trying to find out reasons which are leading to these problems which are caused by microemboli in the brain from using heart lung machine, brain infarction caused by major surgery, thorax tissue trauma after operation or complications under perioperative treatment. Hypothesis is that if a patient is diagnosed with sleep apnea before cabg surgery, are postoperative results connected with postoperative outcomes and recovery. Sleep polygraph is made before surgery and approximately six months after surgery and transthoracic echo and laboratory tests. If connection between sleep quality and coronary bypass surgery can be made, findings can be used in clinical practice.

Total amount of heart lung machine treated patients is waited to be 70. Off pump patient sample size is remarkably smaller so data is collected and compared with main sample population. Operation technique is decided when patient is scheduled to operation. Emergency patients are excluded, because pre- operative researches cannot be performed. Coronary artery disease is causing recruiting challenges, because patients often need urgent care. Other exclusion criteria are night time cpap- treatment and other heart operations (for example valvesurgery) during cabg.

From all of the patients are collected basic information including age, weight, heigh, diseases, medication and medical history. Ekg is registered before and after surgery and sinus or other heart rhythms are recorded. Sleep polygraph six months postoperatively, when the patient is fully recovered from surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

Elective coronary artery bypass surgery

Exclusion Criteria:

• Emergency cabg

• Night time cpap- treatment

• other heart operations (for example valve surgery)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Sleep Apnea Syndromes
• Sleep Disorder
• Sleep Wake Disorders

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	New York Heart Association -classification (NYHA) status	Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.; Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest.; Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients	Before operation
Primary	Incidence of sleep disorders before coronary artery bypass surgery (CABG), polysomnography	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).	Before operation, as soon as operation has scheduled
Primary	Sleep quality before CABG	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.	Before operation, as soon as operation has scheduled
Primary	A transthoracic echocardiogram	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.	Before operation, as soon as operation has scheduled
Secondary	Incidence of sleep disorders after coronary artery bypass surgery, polysomnography	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).	After 6 to 8 months after surgery
Secondary	Sleep quality after CABG	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	After 6 to 8 months after surgery
Secondary	A transthoracic echocardiogram	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.	After operation, 3-5 months after surgery