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Injection Snoreplasty: Comparison Between Ethanol and Ethanolamine Oleate

Primary Purpose

Snoring, Apnea

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Injection Snoreplasty
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Snoring focused on measuring Snoring and Mild Apnea

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Snoring
  • RDI < 15 /h

Exclusion Criteria:

  • BMI > 35

Sites / Locations

  • University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ethanol

Ethanolamine Oleate

Arm Description

Outcomes

Primary Outcome Measures

Snoring

Secondary Outcome Measures

Full Information

First Posted
December 5, 2008
Last Updated
December 5, 2008
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00804037
Brief Title
Injection Snoreplasty: Comparison Between Ethanol and Ethanolamine Oleate
Official Title
Injection Snoreplasty: Comparison Between Ethanol and Ethanolamine Oleate. A Randomized, Placebo-Controlled Study in Human Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snoring, Apnea
Keywords
Snoring and Mild Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ethanol
Arm Type
Active Comparator
Arm Title
Ethanolamine Oleate
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Injection Snoreplasty
Intervention Description
Injection of 0,5 ml of the sclerosing agent into the soft palate (3 points)
Primary Outcome Measure Information:
Title
Snoring
Time Frame
3 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Snoring RDI < 15 /h Exclusion Criteria: BMI > 35
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio TM Lorenzetti, MD
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michel B Cahali, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
University of São Paulo
City
São Paulo
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Injection Snoreplasty: Comparison Between Ethanol and Ethanolamine Oleate

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