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

NCT01026207 | Terminated DMC

• 1 other identifier: CEP1989/08
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Obstructive Pulmonary Disease; Obstructive Sleep Apnea Syndrome

Keywords

Diagnostic test; polysomnography; Obstructive Sleep Apnea Syndrome; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• to evaluate the accuracy of a portable monitoring device (Stardust - STD) in the detection of patients with chronic obstructive pulmonary disease (COPD).

  compared Portable monitoring device with polysomnography in COPD patients

  2 years colect data

Study Arms (1)

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

Interventions

Polysomnography DEVICE

Sleep study polysomnography compared with portable monitoring

Also known as: Sleep study diagnostic

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Presence of Chronic Obstructive Pulmonary Disease stage II and III

Sponsors & Collaborators

• Associação Fundo de Incentivo à Pesquisa: lead
• Federal University of São Paulo: collaborator

Study Sites (2)

Associacao Fundo de Incentivo a Psicofarmacologia

São Paulo, São Paulo, 04024-002, Brazil

Location

Brazil: Associação Fundo de Incentivo à Pesquisa

São Paulo, São Paulo, 04024-002, Brazil

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Sleep Apnea, Obstructive

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Lia A Bittencourt, PhD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr Lia Rita Azeredo Bittencourt

Study Record Dates

• First Submitted: December 3, 2009
• First Posted: December 4, 2009
• Study Start: August 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 23, 2013

Record last verified: 2011-02

Locations

BR (2)