NCT00804037

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2008

Completed
Last Updated

December 8, 2008

Status Verified

November 1, 2008

Enrollment Period

1.9 years

First QC Date

December 5, 2008

Last Update Submit

December 5, 2008

Conditions

SnoringApnea

Keywords

Snoring and Mild Apnea

Outcome Measures

Primary Outcomes (1)

  • Snoring

    3 months after treatment

Study Arms (2)

Ethanol

ACTIVE COMPARATOR
Procedure: Injection Snoreplasty

Ethanolamine Oleate

ACTIVE COMPARATOR
Procedure: Injection Snoreplasty

Interventions

Injection SnoreplastyPROCEDURE

Injection of 0,5 ml of the sclerosing agent into the soft palate (3 points)

EthanolEthanolamine Oleate

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Snoring
  • RDI \< 15 /h

You may not qualify if:

  • BMI \> 35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

SnoringApnea

Condition Hierarchy (Ancestors)

Respiratory SoundsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Fabio TM Lorenzetti, MD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Michel B Cahali, PhD

    University of Sao Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 5, 2008

First Posted

December 8, 2008

Study Start

January 1, 2007

Primary Completion

December 1, 2008

Last Updated

December 8, 2008

Record last verified: 2008-11

Locations

BR(1)