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Injection Snoreplasty: Comparison Between Ethanol and Ethanolamine Oleate

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ClinicalTrials.gov Identifier: NCT00804037
Recruitment Status : Unknown
Verified November 2008 by University of Sao Paulo.
Recruitment status was:  Active, not recruiting
First Posted : December 8, 2008
Last Update Posted : December 8, 2008
Sponsor:
Collaborator:
Information provided by:

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.


Condition or disease Intervention/treatment
Snoring Apnea Procedure: Injection Snoreplasty

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : January 2007
Primary Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Snoring
U.S. FDA Resources

Arms and Interventions

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)


Outcome Measures

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

Eligibility Criteria

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 Posted: December 8, 2008    Key Record Dates
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