Injection Snoreplasty: Comparison Between Ethanol and Ethanolamine Oleate

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

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.

Study Overview

• Status: Unknown
• Conditions: Apnea; Snoring
• Intervention / Treatment: Procedure: Injection Snoreplasty

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil
      • University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Snoring
• RDI < 15 /h

Exclusion Criteria:

• BMI > 35

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ethanol	Procedure: Injection Snoreplasty; Injection of 0,5 ml of the sclerosing agent into the soft palate (3 points)
Active Comparator: Ethanolamine Oleate	Procedure: Injection Snoreplasty; Injection of 0,5 ml of the sclerosing agent into the soft palate (3 points)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Snoring	3 months after treatment

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Principal Investigator: Fabio TM Lorenzetti, MD, University of Sao Paulo; Study Director: Michel B Cahali, PhD, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: December 5, 2008
• First Submitted That Met QC Criteria: December 5, 2008
• First Posted (Estimate): December 8, 2008

Study Record Updates

• Last Update Posted (Estimate): December 8, 2008
• Last Update Submitted That Met QC Criteria: December 5, 2008
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Keywords: Snoring and Mild Apnea
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds; Snoring
• Other Study ID Numbers: ORLHCFMUSP 1