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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00883025
Other study ID # CEP ISCML 113/08
Secondary ID FriedmanAIH
Status Completed
Phase N/A
First received April 16, 2009
Last updated April 16, 2009
Start date February 2007
Est. completion date October 2008

Study information

Verified date April 2009
Source Irmandade da Santa Casa de Misericoridia de Limeira
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.


Recruitment information / eligibility

Status Completed
Enrollment 147
Est. completion date October 2008
Est. primary completion date February 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Not exhibiting any exclusion criteria

- Age > 21 years

Exclusion Criteria:

- Nasal tumor

- BMI > 40

- No acceptance of study

- Nasal poliposis

Study Design


Locations

Country Name City State
Brazil Hospital Dia Limeira São Paulo

Sponsors (2)

Lead Sponsor Collaborator
Irmandade da Santa Casa de Misericoridia de Limeira Hospital Dia

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Friedman Classification one year
Secondary Apnea-Hypopnea Index one year
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