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

This study has been terminated.
(the data was completed.)
Sponsor:
Collaborator:
Federal University of São Paulo
Information provided by (Responsible Party):
Prof. Dr. Lia Azeredo-Bittencourt, Associacao Fundo de Incentivo a Psicofarmcologia
ClinicalTrials.gov Identifier:
NCT01026207
First received: December 3, 2009
Last updated: October 22, 2013
Last verified: February 2011
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Obstructive Sleep Apnea Syndrome
Device: Polysomnography

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of a Portable Monitoring Device for the Diagnosis of Obstructive Sleep Apnea Syndrome in Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Associação Fundo de Incentivo à Pesquisa:

Primary Outcome Measures:
  • to evaluate the accuracy of a portable monitoring device (Stardust - STD) in the detection of patients with chronic obstructive pulmonary disease (COPD). [ Time Frame: 2 years colect data ] [ Designated as safety issue: Yes ]
    compared Portable monitoring device with polysomnography in COPD patients


Enrollment: 72
Study Start Date: August 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Device: Polysomnography
Sleep study polysomnography compared with portable monitoring
Other Name: Sleep study diagnostic

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026207

Locations
Brazil
Associacao Fundo de Incentivo a Psicofarmacologia
Sao Paulo, SP, Brazil, 04024-002
Brazil: Associação Fundo de Incentivo à Pesquisa
São Paulo, SP, Brazil, 04024-002
Sponsors and Collaborators
Associação Fundo de Incentivo à Pesquisa
Federal University of São Paulo
Investigators
Principal Investigator: Lia A Bittencourt, PhD Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Prof. Dr. Lia Azeredo-Bittencourt, Prof Dr Lia Rita Azeredo Bittencourt, Associacao Fundo de Incentivo a Psicofarmcologia
ClinicalTrials.gov Identifier: NCT01026207     History of Changes
Other Study ID Numbers: CEP1989/08
Study First Received: December 3, 2009
Last Updated: October 22, 2013
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: Associação Fundo de Incentivo à Pesquisa

Keywords provided by Associação Fundo de Incentivo à Pesquisa:
Diagnostic test
polysomnography
Obstructive Sleep Apnea Syndrome
Chronic Obstructive Pulmonary Disease

Additional relevant MeSH terms:
Apnea
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 28, 2014