LATERAL PHARYNGOPLASTY OUTCOMES IN THE TREATMENT OF SNORE AND OBSTRUCTIVE SLEEP APNEA

NCT ID: NCT01574768

Last Updated: 2012-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-09-30

Brief Summary

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The aim of this study is to describe the results of Lateral Pharyngoplasty in the treatment of snore and OSAS.

Detailed Description

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Conditions

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Snore Obstructive Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Lateral Pharyngoplasty

Tonsilectomy, microdissection of the superior pharyngeal constrictor muscle within the tonsillar fossa and sectioning of this muscle

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* snore
* osas

Exclusion Criteria

* previous pharynx surgery
* use of medication that modifies the muscular tonus or the perception of sleepiness before or after the surgery
* body mass index (BMI) bigger than 35 kg/m2
* neurological or psychiatric disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role collaborator

Hospital do Servidor Publico Estadual

OTHER

Sponsor Role lead

Responsible Party

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CAROLINA DE ANDRADE FERREIRA VIEIRA

otolaryngologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michel B Cahali, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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Hospital do Servidor Público Estadual

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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135/11

Identifier Type: -

Identifier Source: org_study_id

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