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Injection Snoreplasty: Comparison Between Ethanol and Ethanolamine Oleate

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2008 by University of Sao Paulo.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00804037
First Posted: December 8, 2008
Last Update Posted: December 8, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo
  Purpose

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.


Condition Intervention
Snoring Apnea Procedure: Injection Snoreplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Injection Snoreplasty: Comparison Between Ethanol and Ethanolamine Oleate. A Randomized, Placebo-Controlled Study in Human Patients

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Snoring [ Time Frame: 3 months after treatment ]

Enrollment: 20
Study Start Date: January 2007
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Snoring
  • RDI < 15 /h

Exclusion Criteria:

  • BMI > 35
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804037


Locations
Brazil
University of São Paulo
São Paulo, SP, Brazil
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Fabio TM Lorenzetti, MD University of São Paulo
Study Director: Michel B Cahali, PhD University of São Paulo
  More Information

Responsible Party: Fabio Lorenzetti, University of São Paulo
ClinicalTrials.gov Identifier: NCT00804037     History of Changes
Other Study ID Numbers: ORLHCFMUSP 1
First Submitted: December 5, 2008
First Posted: December 8, 2008
Last Update Posted: December 8, 2008
Last Verified: November 2008

Keywords provided by University of Sao Paulo:
Snoring and Mild Apnea

Additional relevant MeSH terms:
Snoring
Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms
Ethanol
Ethanolamine oleate
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Sclerosing Solutions
Pharmaceutical Solutions