Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Validation of a Portable Monitoring Device for the Diagnosis of Obstructive Sleep Apnea Syndrome in Patients With Chronic Obstructive Pulmonary Disease
Introduction:
The prevalence of overlap between Chronic Obstructive Pulmonary Disease (COPD) and
Obstructive Sleep Apnea Syndrome (OSAS) is around 10%. This overlap syndrome is an important
issue because is related to nocturnal desaturation and its complications. The use of
portable monitoring devices (PM) for the diagnosis of OSAS was recently accepted as an
alternative to full-night polysomnography (PSG). However, there are not studies evaluating
the PM recording in COPD patients to detect or exclude OSAS.
Objective:
To evaluate if a PM (Stardust®, Respironics, Inc, USA) could accurately measure the
apnea-hypopnea index (AHI) in COPD patients with a suspicion of OSAS.
Patients will be recruited from the Pneumology outpatient clinic of UNIFESP, Patients had
been diagnosed with COPD in GOLD's stages II and III, were stable (no COPD exacerbation in
the last three months), were using bronchodilators without a dose change during that period,
and had symptoms suggestive of OSAS (loud snoring, reported breathing pauses during sleep
and excessive sleepiness). We excluded patients with other sleep-related disorders, a
diagnosis and/or previous treatment for OSAS, severe cardiovascular disorders or
neuromuscular disease and those using oxygen, psychotropic drugs, alcohol or other drugs of
abuse.
Patients will undergo two assessments of sleep, randomly determined: 1) PM at home for one
night, 2) PM in the sleep laboratory simultaneously to the PSG. Three apnea-hypopnea index
(AHI) values will be obtained and analyzed: a) AHI from PM at home, b) AHI from PM in the
laboratory, and c) AHI from the PSG. Analyses of all evaluations will be performed by two
trained technicians, blinded to study details.
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