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Evaluation of Swallowing in Patients With Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luciana Almeida Moreira da Paz Oliveira, Hospital do Servidor Publico Estadual
ClinicalTrials.gov Identifier:
NCT01335594
First received: April 11, 2011
Last updated: April 7, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention
Sleep Apnea, Obstructive
 Procedure: clinical, endoscopical and manometric evaluation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical, Endoscopical and Manometric Evaluation of Swallowing in Obstructive Sleep Apnea Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital do Servidor Publico Estadual:

Primary Outcome Measures:
  • Clinical evaluation of swallowing in obstructive sleep apnea [ Time Frame: within the first 3 months after diagnostic ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Manometric evaluation of swallowing in obstructive sleep apnea [ Time Frame: within the first 3 months after diagnostic ] [ Designated as safety issue: No ]
  • Endoscopic evaluation of swallowing in obstructive sleep apnea [ Time Frame: within the first 3 months after diagnostic ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: February 2010
Study Completion Date: May 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: clinical, endoscopical and manometric evaluation
    clinical evaluation: questionnaire endoscopical analysis manometry
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 11, 2011
Last Updated: April 7, 2012
Health Authority: Brazil: National Agency of health

Keywords provided by Hospital do Servidor Publico Estadual:
Sleep apnea, obstructive
Deglutition Disorders
Manometry
Endoscopy

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

ClinicalTrials.gov processed this record on May 22, 2013