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NCT00804037 Clinical Trial

Injection Snoreplasty: Comparison Between Ethanol and Ethanolamine Oleate

Apnea Clinical Trial

Official title:
Injection Snoreplasty: Comparison Between Ethanol and Ethanolamine Oleate. A Randomized, Placebo-Controlled Study in Human Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00804037
Other study ID # ORLHCFMUSP 1
Secondary ID
Status Active, not recruiting
Phase N/A
First received December 5, 2008
Last updated December 5, 2008
Start date January 2007

Study information
Verified date November 2008
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 20
Est. completion date
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Snoring

- RDI < 15 /h

Exclusion Criteria:

- BMI > 35

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Brazil University of São Paulo São Paulo SP

Sponsors (2)
Lead Sponsor Collaborator
University of Sao Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Snoring 3 months after treatment Yes
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