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Evaluation Of The Pharynx in Patients Undergoing Lateral Pharyngoplasty

Primary Purpose

Sleep Apnea, Obstructive

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
LATERAL PHARYNGOPLASTY
Sponsored by
Hospital do Servidor Publico Estadual
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Magnetic Resonance Imaging, Sleep Apnea, Obstructive, Pharyngeal Muscles

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of obstructive sleep apnea syndrome

Exclusion Criteria:

  • MRI contraindications

Sites / Locations

  • Hospital Do Servidor Publico Estadual

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

lateral pharyngoplasty

Arm Description

lateral pharyngoplasty

Outcomes

Primary Outcome Measures

expansion of pharynx

Secondary Outcome Measures

Full Information

First Posted
August 30, 2011
Last Updated
April 7, 2012
Sponsor
Hospital do Servidor Publico Estadual
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1. Study Identification

Unique Protocol Identification Number
NCT01427075
Brief Title
Evaluation Of The Pharynx in Patients Undergoing Lateral Pharyngoplasty
Official Title
Evaluation of the Pharynx Through MRI in Patients Undergoing Lateral Pharyngoplasty for Treatment of Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
November 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital do Servidor Publico Estadual

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
Magnetic Resonance Imaging, Sleep Apnea, Obstructive, Pharyngeal Muscles

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lateral pharyngoplasty
Arm Type
Experimental
Arm Description
lateral pharyngoplasty
Intervention Type
Procedure
Intervention Name(s)
LATERAL PHARYNGOPLASTY
Intervention Description
tonsilectomy and lateral pharyngoplasty
Primary Outcome Measure Information:
Title
expansion of pharynx
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of obstructive sleep apnea syndrome Exclusion Criteria: MRI contraindications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CAROLINA AF VIEIRA, MD
Organizational Affiliation
Hospital do Servidor Publico Estadual
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Do Servidor Publico Estadual
City
Sao Paulo
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Evaluation Of The Pharynx in Patients Undergoing Lateral Pharyngoplasty

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