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Portable Monitoring Device for the Diagnosis of Sleep Apnea in Patients With Chronic Obstructive Pulmonary Disease

NCT ID: NCT01026207

Last Updated: 2013-10-23

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

TERMINATED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease Obstructive Sleep Apnea Syndrome

Keywords

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Diagnostic test polysomnography Obstructive Sleep Apnea Syndrome Chronic Obstructive Pulmonary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic Obstructive Pulmonary Disease

Patients recruited from the Pneumology Clinic of UNIFESP, diagnosed with COPD stage II and III of Global Initiative for Chronic Obstructive Lung Disease, stable for three months, and with symptoms suggestive of Obstructive Sleep Apnea Syndrome.Patients has been underwent one night by polysomnography and one night with portable monitoring.

Polysomnography

Intervention Type DEVICE

Sleep study polysomnography compared with portable monitoring

Interventions

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Polysomnography

Sleep study polysomnography compared with portable monitoring

Intervention Type DEVICE

Other Intervention Names

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Sleep study diagnostic

Eligibility Criteria

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Inclusion Criteria

* Presence of Chronic Obstructive Pulmonary Disease stage II and III of Global Initiative for Chronic Obstructive Lung Disease, stable for three months, and with symptoms suggestive of Obstructive Sleep Apnea Syndrome.

Exclusion Criteria

* Presence of Chronic Obstructive Pulmonary Disease stage II and III
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role collaborator

Associação Fundo de Incentivo à Pesquisa

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Lia Azeredo-Bittencourt

Prof Dr Lia Rita Azeredo Bittencourt

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lia A Bittencourt, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

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Associacao Fundo de Incentivo a Psicofarmacologia

São Paulo, São Paulo, Brazil

Site Status

Brazil: Associação Fundo de Incentivo à Pesquisa

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CEP1989/08

Identifier Type: -

Identifier Source: org_study_id