Evaluation of Swallowing in Patients With Obstructive Sleep Apnea

April 7, 2012 updated by: Luciana Almeida Moreira da Paz Oliveira

Clinical, Endoscopical and Manometric Evaluation of Swallowing in Obstructive Sleep Apnea Syndrome

The purpose of this study is to test the hypothesis that obstructive sleep apnea syndrome is associated with deviant pharyngeal swallowing function, using clinical, endoscopical and manometric evaluation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

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
      • São Paulo, Brazil
        • Instituto de Assistência Médica ao 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of obstructive sleep apnea syndrome

Exclusion Criteria:

  • other causes of dysphagia
  • pharyngeal surgery
  • prior treatment for obstructive sleep apnea

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical evaluation of swallowing in obstructive sleep apnea
Time Frame: within the first 3 months after diagnostic
within the first 3 months after diagnostic

Secondary Outcome Measures

Outcome Measure
Time Frame
Manometric evaluation of swallowing in obstructive sleep apnea
Time Frame: within the first 3 months after diagnostic
within the first 3 months after diagnostic
Endoscopic evaluation of swallowing in obstructive sleep apnea
Time Frame: within the first 3 months after diagnostic
within the first 3 months after diagnostic

Collaborators and Investigators

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

Sponsor

Luciana Almeida Moreira da Paz Oliveira

Investigators

  • Principal Investigator: Luciana A M da Paz Oliveira, Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

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

February 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

April 11, 2011

First Submitted That Met QC Criteria

April 13, 2011

First Posted (Estimate)

April 14, 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

  • SAOS2011

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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