Injection Snoreplasty: Comparison Between Ethanol and Ethanolamine Oleate

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	University of Sao Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00804037

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

MedlinePlus related topics: Snoring

Drug Information available for: Ethanol Oleic acid Ethanolamine Ethanolamine oleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment
Official Title:	Injection Snoreplasty: Comparison Between Ethanol and Ethanolamine Oleate. A Randomized, Placebo-Controlled Study in Human Patients

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
Ethanol: Active Comparator	Procedure: Injection Snoreplasty Injection of 0,5 ml of the sclerosing agent into the soft palate (3 points)
Ethanolamine Oleate: Active Comparator	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, SP
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:	University of São Paulo ( Fabio Lorenzetti )
Study ID Numbers:	ORLHCFMUSP 1
Study First Received:	December 5, 2008
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00804037
Health Authority:	Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:

Snoring and Mild Apnea

Study placed in the following topic categories:

Signs and Symptoms
Respiratory Sounds
Apnea
Ethanolamine oleate

Snoring
Signs and Symptoms, Respiratory
Ethanol

Additional relevant MeSH terms:

Therapeutic Uses
Sclerosing Solutions
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009