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Sleep Quality and Sleep-disordered Breathing in Bypass Surgery Patients

Sleep Quality and Sleep-disordered Breathing in Bypass Surgery Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06453538
Acronym
UNI-CABG
Enrollment
54
Registered
2024-06-11
Start date
2023-02-01
Completion date
2025-12-30
Last updated
2024-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Sleep Disorder

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).

Interventions

None listed

Sponsors

Turku University Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

Elective coronary artery bypass surgery

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
A transthoracic echocardiogramBefore operation, as soon as operation has scheduledLeft 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 before coronary artery bypass surgery (CABG), polysomnographyBefore operation, as soon as operation has scheduledApnea-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 CABGBefore operation, as soon as operation has scheduledESS, 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.

Secondary

MeasureTime frameDescription
A transthoracic echocardiogramAfter operation, 3-5 months after surgeryLeft 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, polysomnographyAfter 6 to 8 months after surgeryApnea-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 after CABGAfter 6 to 8 months after surgeryESS, 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

Other

MeasureTime frameDescription
New York Heart Association -classification (NYHA) statusBefore operationClass 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

Countries

Finland

Contacts

Primary ContactMarjo Ajosenpää, MD
marjo.ajosenpaa@varha.fi+35823133247
Backup ContactJenni Toivonen, millä Associate Professor
jenni.toivonen@varha.fi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026