Sleep ApneaNCT00989885
ESS as a Diagnosis Resource Aid of the Syndrome of Obstructive Sleep Apnea
An observational study of Sleep Apnea and Mixed Central and Obstructive Sleep Apnea, run by Fortaleza University at 1 site in Brazil.
Trial summary
The aim of this study was to analyze the effectiveness of the Epworth's sleepiness scale as a recourse aid in the diagnosis of the syndrome of obstructive sleep apnea. 475 patients attended this study, that sought the CESF to probable diagnosis of some sleep disorder. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Sleep Apnea, Mixed Central and Obstructive Sleep Apnea, Sleep-Disordered Breathing
- What is being tested?
- Questionnaire and polysomnography
- How many people
- 475 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2007to Jul 2007
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients that sought the CESF to probable diagnosis of some sleep disorder
Who may be able to join
- Charts of whose admission of patients was from October 2005 to July 2007
- Patients referred to the CESF for possible diagnosis of a sleep disorder
Who cannot join
- incomplete data
- patients with concomitant diseases (heart disease, hormonal disease, chronic obstructive pulmonary disease and neurological patients)
- patients undergoing uvulopalatopharyngoplasty
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Fortaleza University - Nucleus of Integrated Medical Attention
Fortaleza, Ceará
About this study
Official title: The Effectiveness of the Epworth´s Sleepiness Scale as a Resource Aid in the Diagnosis of the Syndrome of Obstructive Sleep Apnea
The aim of this study was to analyze the effectiveness of the Epworth's sleepiness scale as a recourse aid in the diagnosis of the syndrome of obstructive sleep apnea. 475 patients attended this study, that sought the CESF to probable diagnosis of some sleep disorder. The data were collected from records, wich are of questionnaires, including the ESE, prepared by the CESF professionals and responded, previously, by the own patients. The study compared the result obtained in the scale of Epworth with the data of polysomnography. The analysis of data was performed using the SPSS, based on descriptive and inferential statistics, being used the average considering the standard deviation, and, to the crossing of variables, was used the chi-square test of Pearson, considering as significant statistically values of p<0.05. The results showed that gender, age and BMI are predisposing factors to SOSA.
- Being tested
- Questionnaire and polysomnography
- Keywords
- Evaluation, Obstructive sleep apnea, Polysomnography
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and polysomnographyOther
Comparison of polysomnography data records and previously made questionnaire, with the Epworth Sleepiness Scale.
| Study group | Role | What they receive |
|---|---|---|
| Obstructive Sleep Apnea | 475 patients that sought the CESF to probable diagnosis of some sleep disorder, subsequently diagnosed with Obstructive Sleep Apnea. Receives: Other: Questionnaire and polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epworth's sleepiness scale
Measured: March 2007
Secondary outcomes (1)
Polysomnography
Measured: May 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2009 (estimated)
- Study startJan 2007
- Primary completionMar 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fortaleza University
- Sponsor type
- University, hospital or other
- Collaborators
- CESF - Centro de Estudos do Sono de Fortaleza LTDA
- Investigators
- Ingrid C Nogueira, Bachelor, Principal investigator, Fortaleza UniversityAna Cristhina O Brasil, Master, Study director, Fortaleza UniversityPriscilla O Azevedo, Bachelor, Principal investigator, Fortaleza UniversityVera Maria A Lacerda, Bachelor, Principal investigator, Fortaleza University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989885
- Sponsor's protocol ID
- FR132544
- Status last verified
- Oct 2009
- First submitted
- 5 Oct 2009
- Last updated
- 6 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Epworth´s Sleepiness Scale as a Resource Aid in the Diagnosis of the Syndrome of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00989885
- Acronym / sponsor ID
- FR132544
- Keywords
- Evaluation, Obstructive sleep apnea, Polysomnography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- Fortaleza UniversityUniversity, hospital or other
- Collaborators
- CESF - Centro de Estudos do Sono de Fortaleza LTDA
- Study start
- Jan 2007
- Primary completion
- Mar 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 6 Oct 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.
The aim of this study was to analyze the effectiveness of the Epworth's sleepiness scale as a recourse aid in the diagnosis of the syndrome of obstructive sleep apnea. 475 patients attended this study, that sought the CESF to probable diagnosis of some sleep disorder. The data were collected from records, wich are of questionnaires, including the ESE, prepared by the CESF professionals and responded, previously, by the own patients. The study compared the result obtained in the scale of Epworth with the data of polysomnography. The analysis of data was performed using the SPSS, based on descriptive and inferential statistics, being used the average considering the standard deviation, and, to the crossing of variables, was used the chi-square test of Pearson, considering as significant statistically values of p<0.05. The results showed that gender, age and BMI are predisposing factors to SOSA.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obstructive Sleep Apnea | – | Other: Questionnaire and polysomnography475 patients that sought the CESF to probable diagnosis of some sleep disorder, subsequently diagnosed with Obstructive Sleep Apnea. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients that sought the CESF to probable diagnosis of some sleep disorder
Key inclusion criteria (2 listed)
- Charts of whose admission of patients was from October 2005 to July 2007
- Patients referred to the CESF for possible diagnosis of a sleep disorder
Key exclusion criteria (3 listed)
- incomplete data
- patients with concomitant diseases (heart disease, hormonal disease, chronic obstructive pulmonary disease and neurological patients)
- patients undergoing uvulopalatopharyngoplasty
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 |
|---|---|---|
| Questionnaire and polysomnographyComparison of polysomnography data records and previously made questionnaire, with the Epworth Sleepiness Scale. | Other | Obstructive Sleep Apnea |
Primary outcome
Epworth's sleepiness scale
Time frame: March 2007
1 secondary outcome
Polysomnography
Time frame: May 2007
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2009.
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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.
Ingrid C Nogueira, Bachelor principal investigator
Fortaleza University
Ana Cristhina O Brasil, Master study director
Fortaleza University
Priscilla O Azevedo, Bachelor principal investigator
Fortaleza University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea and Mixed Central and Obstructive Sleep Apnea, run by Fortaleza University at 1 site 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 6 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Epworth's sleepiness scale (time frame: March 2007). 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 6 Oct 2009.