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Injection Snoreplasty: Comparison Between Ethanol and Ethanolamine Oleate

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by University of Sao Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00804037
First received: December 5, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  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 Blind (Subject, 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:

MedlinePlus related topics: Snoring
U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Snoring [ Time Frame: 3 months after treatment ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Snoring
  • RDI < 15 /h

Exclusion Criteria:

  • BMI > 35
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Fabio Lorenzetti, University of São Paulo
ClinicalTrials.gov Identifier: NCT00804037     History of Changes
Other Study ID Numbers: ORLHCFMUSP 1
Study First Received: December 5, 2008
Last Updated: December 5, 2008
Health Authority: Brazil: Ethics Committee

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

Additional relevant MeSH terms:
Apnea
Snoring
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiratory Sounds
Ethanol
Ethanolamine oleate
 Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Sclerosing Solutions
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 22, 2013