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Injection Snoreplasty: Comparison Between Ethanol and Ethanolamine Oleate

NCT ID: NCT00804037

Last Updated: 2008-12-08

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Brief Summary

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SUMMARY INTRODUCTION: among various treatments for patients with primary snoring, upper airway resistance syndrome (UARS) and obstructive sleep apnea syndrome (OSAS), the injection snoreplasty arose as a promising alternative in some selected cases.

OBJECTIVE: to investigate the efficacy and tolerance of injection snoreplasty comparing Ethanol and Ethanolamine Oleate.

Detailed Description

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Conditions

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Snoring Apnea

Keywords

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Snoring and Mild Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ethanol

Group Type ACTIVE_COMPARATOR

Injection Snoreplasty

Intervention Type PROCEDURE

Injection of 0,5 ml of the sclerosing agent into the soft palate (3 points)

Ethanolamine Oleate

Group Type ACTIVE_COMPARATOR

Injection Snoreplasty

Intervention Type PROCEDURE

Injection of 0,5 ml of the sclerosing agent into the soft palate (3 points)

Interventions

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Injection Snoreplasty

Injection of 0,5 ml of the sclerosing agent into the soft palate (3 points)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Snoring
* RDI \< 15 /h

Exclusion Criteria

* BMI \> 35
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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University of São Paulo

Principal Investigators

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Fabio TM Lorenzetti, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Michel B Cahali, PhD

Role: STUDY_DIRECTOR

University of Sao Paulo

Locations

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University of São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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ORLHCFMUSP 1

Identifier Type: -

Identifier Source: org_study_id