Pre-operative Polysomnography Assessment of Cardiac Surgery Inpatients

Cleveland Medical Devices

Status: Completed

Conditions: Sleep Disordered Breathing; Central Sleep Apnea; Obstructive Sleep Apnea

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT00922168

Pre-op PSG

R44NS042451 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to assess the prevalence and morbidity rates of sleep disordered breathing in cardiac surgery patients.

Enrollment: 146 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects undergoing major cardiovascular surgery (coronary artery bypass graft, valve replacement surgery, or aortic surgery) under general anesthesia.
• Subjects in whom surgery is planned for greater than 1 day but less than 60 days from the time of enrollment.

Exclusion criteria

• Subjects treated for sleep apnea with positive airway pressure (PAP) therapy or oral appliance in the past 30 days.
• Subjects undergoing Maze procedure for atrial fibrillation.
• Subjects unable to comply with study procedures.

Trial design

146 participants in 1 patient group

Cardiac Surgeries: CABG, valve replacements