Sleep Quality and Sleep-disordered Breathing in Bypass Surgery Patients

NCT ID: NCT06453538

Last Updated: 2024-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-12-30

Brief Summary

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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

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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).

Conditions

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Sleep Disorder Coronary Artery Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Elective coronary artery bypass surgery

Exclusion Criteria

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

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Marjo Ajosenpää

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nea Kalleinen, millä Associate Professor

Role: STUDY_DIRECTOR

Turku University Hospital/Heart Center

Locations

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Turku University Hospital

Turku, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Marjo Ajosenpää, MD

Role: CONTACT

+35823133247

Jenni Toivonen, millä Associate Professor

Role: CONTACT

Facility Contacts

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Jenni Toivonen, millä Associate Professor

Role: primary

Other Identifiers

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27 /1801/2022

Identifier Type: -

Identifier Source: org_study_id

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