Overview

This trial is active, not recruiting.

Conditions snoring, apnea
Treatment injection snoreplasty
Sponsor University of Sao Paulo
Collaborator Fundação de Amparo à Pesquisa do Estado de São Paulo
Start date January 2007
End date December 2008
Trial size 20 participants
Trial identifier NCT00804037, ORLHCFMUSP 1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
injection snoreplasty
Injection of 0,5 ml of the sclerosing agent into the soft palate (3 points)
(Active Comparator)
injection snoreplasty
Injection of 0,5 ml of the sclerosing agent into the soft palate (3 points)

Primary Outcomes

Measure
Snoring
time frame: 3 months after treatment

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Snoring - RDI < 15 /h Exclusion Criteria: - BMI > 35

Additional Information

Official title Injection Snoreplasty: Comparison Between Ethanol and Ethanolamine Oleate. A Randomized, Placebo-Controlled Study in Human Patients
Principal investigator Fabio TM Lorenzetti, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2008.
Information provided to ClinicalTrials.gov by University of Sao Paulo.