Obstructive Sleep Apnea SyndromeFriedmAIHNCT00883025
Correlation Between Friedman Classification and the Apnea Hypopnea Index (AIH) in a Population With Obstructive Sleep Apnea Syndrome (OSAS)
An observational study of Obstructive Sleep Apnea Syndrome, run by Irmandade da Santa Casa de Misericoridia de Limeira at 1 site in Brazil.
Trial summary
Introduction: OSAS is an important disease in the actual medic scene. It is important for correlation with chronic cardiovascular disease that leaves an increase in morbimortality and socioeconomic disability to patients with apnea. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- How many people
- 147 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2007to Oct 2008
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients of Ambulatory of Sleep Respiratory Disorders of Santa Casa de Limeira
Who may be able to join
- Not exhibiting any exclusion criteria
- Age > 21 years
Who cannot join
- Nasal tumor
- BMI > 40
- No acceptance of study
- Nasal poliposis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Friedman Classification Ande ApneaHypopnea Index in a Population With OSAS
Introduction:
OSAS is an important disease in the actual medic scene. It is important for correlation with chronic cardiovascular disease that leaves an increase in morbimortality and socioeconomic disability to patients with apnea.
Objectives:
Determinate the correlation between Friedman Classification and the obstructive sleep apnea syndrome (OSAS) gravity through AHI (Apnea Hypopnea Index) in patients with OSAS for surgical indication and evaluation.
Materials and Methods:
The investigators evaluated and classified 84 patients, in the scale of Epworth, Friedman and how much the gravity of the SAHOS for the AHI.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- Friedman Classification, Apnea-Hypopnea Index, Obstructive Sleep Apnea Syndrome
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | OSAS patients | |
| 2 | no OSAS Patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Friedman Classification
Measured: one year
Secondary outcomes (1)
Apnea-Hypopnea Index
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startFeb 2007
- Primary completionFeb 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies 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
- Cross-sectional
- Enrolment
- 147 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Irmandade da Santa Casa de Misericoridia de Limeira
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Dia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883025
- Sponsor's protocol ID
- CEP ISCML 113/08
- Other IDs
- FriedmanAIH
- Acronym
- FriedmAIH
- Status last verified
- Apr 2009
- First submitted
- 16 Apr 2009
- Last updated
- 17 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Rodrigues MM, Dibbern RS, Santos VJ, Passeri LA. Influence of obesity on the correlation between laryngopharyngeal reflux and obstructive sleep apnea. Braz J Otorhinolaryngol. 2014 Jan-Feb;80(1):5-10. doi: 10.5935/1808-8694.20140004. English, Portuguese.
PubMed 24626885
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Friedman Classification Ande ApneaHypopnea Index in a Population With OSAS
- ClinicalTrials.gov ID
- NCT00883025
- Acronym / sponsor ID
- FriedmAIH / CEP ISCML 113/08
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- Friedman Classification, Apnea-Hypopnea Index, Obstructive Sleep Apnea Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- Irmandade da Santa Casa de Misericoridia de LimeiraUniversity, hospital or other
- Collaborators
- Hospital Dia
- Study start
- Feb 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 17 Apr 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:
OSAS is an important disease in the actual medic scene. It is important for correlation with chronic cardiovascular disease that leaves an increase in morbimortality and socioeconomic disability to patients with apnea.
Objectives:
Determinate the correlation between Friedman Classification and the obstructive sleep apnea syndrome (OSAS) gravity through AHI (Apnea Hypopnea Index) in patients with OSAS for surgical indication and evaluation.
Materials and Methods:
The investigators evaluated and classified 84 patients, in the scale of Epworth, Friedman and how much the gravity of the SAHOS for the AHI.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –OSAS patients |
| 2 | – | –no OSAS Patient |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of Ambulatory of Sleep Respiratory Disorders of Santa Casa de Limeira
Key inclusion criteria (2 listed)
- Not exhibiting any exclusion criteria
- Age > 21 years
Key exclusion criteria (4 listed)
- Nasal tumor
- BMI > 40
- No acceptance of study
- Nasal poliposis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Friedman Classification
Time frame: one year
1 secondary outcome
Apnea-Hypopnea Index
Time frame: one year
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 17 Apr 2009.
- Derived from this study: PubMed 24626885Rodrigues MM, Dibbern RS, Santos VJ, Passeri LA. Influence of obesity on the correlation between laryngopharyngeal reflux and obstructive sleep apnea. Braz J Otorhinolaryngol. 2014 Jan-Feb;80(1):5-10. doi: 10.5935/1808-8694.20140004. English, Portuguese.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Obstructive Sleep Apnea Syndrome, run by Irmandade da Santa Casa de Misericoridia de Limeira 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 4 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 17 Apr 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?
Friedman Classification (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00883025, which also lists 1 linked publication.
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 17 Apr 2009.