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Evaluation of Swallowing in Patients With Obstructive Sleep Apnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01335594
Recruitment Status : Completed
First Posted : April 14, 2011
Last Update Posted : April 10, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Sleep Apnea, Obstructive Procedure: clinical, endoscopical and manometric evaluation

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical, Endoscopical and Manometric Evaluation of Swallowing in Obstructive Sleep Apnea Syndrome
Study Start Date : February 2010
Primary Completion Date : December 2010
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Procedure: clinical, endoscopical and manometric evaluation
    clinical evaluation: questionnaire endoscopical analysis manometry

Outcome Measures

Primary Outcome Measures :
  1. Clinical evaluation of swallowing in obstructive sleep apnea [ Time Frame: within the first 3 months after diagnostic ]

Secondary Outcome Measures :
  1. Manometric evaluation of swallowing in obstructive sleep apnea [ Time Frame: within the first 3 months after diagnostic ]
  2. Endoscopic evaluation of swallowing in obstructive sleep apnea [ Time Frame: within the first 3 months after diagnostic ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of obstructive sleep apnea syndrome

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335594


Locations
Brazil
Instituto de Assistência Médica ao Servidor Público Estadual
São Paulo, Brazil
Sponsors and Collaborators
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
More Information

Responsible Party: Luciana Almeida Moreira da Paz Oliveira, physician, Hospital do Servidor Publico Estadual
ClinicalTrials.gov Identifier: NCT01335594     History of Changes
Other Study ID Numbers: SAOS2011
First Posted: April 14, 2011    Key Record Dates
Last Update Posted: April 10, 2012
Last Verified: April 2012

Keywords provided by Luciana Almeida Moreira da Paz Oliveira, Hospital do Servidor Publico Estadual:
Sleep apnea, obstructive
Deglutition Disorders
Manometry
Endoscopy

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Dyssomnias
Nervous System Diseases