NCT00883025

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2009

Completed
Last Updated

April 17, 2009

Status Verified

April 1, 2009

Enrollment Period

1 year

First QC Date

April 16, 2009

Last Update Submit

April 16, 2009

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

Friedman ClassificationApnea-Hypopnea IndexObstructive Sleep Apnea Syndrome

Outcome Measures

Primary Outcomes (1)

  • Friedman Classification

    one year

Secondary Outcomes (1)

  • Apnea-Hypopnea Index

    one year

Study Arms (2)

1

OSAS patients

2

no OSAS Patient

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Study Population

Patients of Ambulatory of Sleep Respiratory Disorders of Santa Casa de Limeira

You may not qualify if:

  • Age \> 21 years
  • Nasal tumor
  • BMI \> 40
  • No acceptance of study
  • Nasal poliposis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Dia

Limeira, São Paulo, 13485051, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 24626885DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 16, 2009

First Posted

April 17, 2009

Study Start

February 1, 2007

Primary Completion

February 1, 2008

Study Completion

October 1, 2008

Last Updated

April 17, 2009

Record last verified: 2009-04

Locations

BR(1)