Ignite Creation Date:
2024-05-05 @ 10:06 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01026207
Status:
TERMINATED
Last Update Posted:
2013-10-23
First Post:
2009-12-03
Brief Title:
Portable Monitoring Device for the Diagnosis of Sleep Apnea in Patients With Chronic Obstructive Pulmonary Disease
Sponsor:
Associação Fundo de Incentivo à Pesquisa
Organization:
Associação Fundo de Incentivo à Pesquisa
Study Overview
Official Title:
Validation of a Portable Monitoring Device for the Diagnosis of Obstructive Sleep Apnea Syndrome in Patients With Chronic Obstructive Pulmonary Disease
Status:
TERMINATED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
the data was completed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
Patients will be recruited from the Pneumology outpatient clinic of UNIFESP Patients had been diagnosed with COPD in GOLDs 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 andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None