Evaluation Of The Pharynx in Patients Undergoing Lateral Pharyngoplasty

April 7, 2012 updated by: CAROLINA DE ANDRADE FERREIRA VIEIRA, Hospital do Servidor Publico Estadual

Evaluation of the Pharynx Through MRI in Patients Undergoing Lateral Pharyngoplasty for Treatment of Obstructive Sleep Apnea

This study will evaluate the pharynx in patients undergoing lateral pharyngoplasty for treatment of obstructive sleep apnea through MRI, before and 6 months after surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil
        • Hospital do Servidor Público Estadual

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of obstructive sleep apnea syndrome

Exclusion Criteria:

  • MRI contraindications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lateral pharyngoplasty
Procedure: LATERAL PHARYNGOPLASTY
tonsilectomy and lateral pharyngoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
expansion of pharynx
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital do Servidor Publico Estadual

Investigators

  • Principal Investigator: CAROLINA AF VIEIRA, MD, Hospital do Servidor Público Estadual

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

August 30, 2011

First Submitted That Met QC Criteria

August 31, 2011

First Posted (Estimate)

September 1, 2011

Study Record Updates

Last Update Posted (Estimate)

April 10, 2012

Last Update Submitted That Met QC Criteria

April 7, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 018/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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