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
About this trial
This is an interventional treatment trial for Snoring focused on measuring Snoring and Mild Apnea
Eligibility Criteria
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
NCT ID
NCT00804037
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
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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