Chronic Obstructive Pulmonary DiseaseNCT01026207
Portable Monitoring Device for the Diagnosis of Sleep Apnea in Patients With Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease and Obstructive Sleep Apnea Syndrome, run by Associação Fundo de Incentivo à Pesquisa at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Obstructive Sleep Apnea Syndrome
- What is being tested?
- Polysomnography
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- 2 sitesBrazil
- Study dates
- Aug 2009to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Presence of Chronic Obstructive Pulmonary Disease stage II and III
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Associacao Fundo de Incentivo a Psicofarmacologia
São Paulo, São Paulo, 04024-002
Brazil: Associação Fundo de Incentivo à Pesquisa
São Paulo, São Paulo, 04024-002
About this study
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.
Read the 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.
- Being tested
- Polysomnography
- Keywords
- Diagnostic test, polysomnography, Obstructive Sleep Apnea Syndrome, Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyDevice
Also called Sleep study diagnostic
Sleep study polysomnography compared with portable monitoring
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years colect data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: the data was completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associação Fundo de Incentivo à Pesquisa
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of São Paulo
- Responsible party
- Principal investigator, Prof. Dr. Lia Azeredo-Bittencourt, Associacao Fundo de Incentivo a Psicofarmcologia
- Investigators
- Lia A Bittencourt, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026207
- Sponsor's protocol ID
- CEP1989/08
- Status last verified
- Feb 2011
- First submitted
- 3 Dec 2009
- Last updated
- 23 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Portable Monitoring Device for the Diagnosis of Obstructive Sleep Apnea Syndrome in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01026207
- Acronym / sponsor ID
- CEP1989/08
- Keywords
- Diagnostic test, polysomnography, Obstructive Sleep Apnea Syndrome, Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: the data was completed.
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Associação Fundo de Incentivo à PesquisaUniversity, hospital or other
- Collaborators
- Federal University of São Paulo
- Study start
- Aug 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | – | Device: PolysomnographyPatients 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Presence of Chronic Obstructive Pulmonary Disease stage II and III
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolysomnographyAlso: Sleep study diagnosticSleep study polysomnography compared with portable monitoring | Device | Chronic Obstructive Pulmonary Disease |
Primary outcome
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
compared Portable monitoring device with polysomnography in COPD patients
Results and safety
The study was stopped early (reason given: the data was completed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lia A Bittencourt, PhD principal investigator
Federal University of São Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Obstructive Sleep Apnea Syndrome, run by Associação Fundo de Incentivo à Pesquisa at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: the data was completed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2013.