Injection Snoreplasty: Comparison Between Ethanol and Eth... | NCT00804037

Studies
Injection Snoreplasty: Comparison Between Ethanol and Ethanolamine Oleate

NCT00804037

Sponsor

University of Sao Paulo

Status

Unknown status

Last Update Posted

Dec 8, 2008Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Snoring
Apnea

Interventions

Injection Snoreplasty

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Dec 2008Actual

Completion Date

Not provided

First Submitted Date

Dec 5, 2008

First Submission Date that Met QC Criteria

Dec 5, 2008

First Posted Date

Dec 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2008

Last Update Posted Date

Dec 8, 2008Estimated

Name	Class
Fundação de Amparo à Pesquisa do Estado de São Paulo	OTHER_GOV

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ethanol	Active Comparator		Procedure: Injection Snoreplasty
Ethanolamine Oleate	Active Comparator		Procedure: Injection Snoreplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Injection Snoreplasty	Procedure	Injection of 0,5 ml of the sclerosing agent into the soft palate (3 points)	Ethanol Ethanolamine Oleate

Measure	Description	Time Frame
Snoring		3 months after treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Snoring
RDI < 15 /h

Exclusion Criteria:

BMI > 35

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fabio TM Lorenzetti, MD	University of Sao Paulo	Principal Investigator
Michel B Cahali, PhD	University of Sao Paulo	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of São Paulo		São Paulo	São Paulo		Brazil

Condition Browse Module

MeSH Terms

ID	Term
D012913	Snoring
D001049	Apnea

Ancestor Terms

ID	Term
D012135	Respiratory Sounds
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided