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Evaluation Of The Pharynx in Patients Undergoing Lateral Pharyngoplasty

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CAROLINA DE ANDRADE FERREIRA VIEIRA, Hospital do Servidor Publico Estadual
ClinicalTrials.gov Identifier:
NCT01427075
First received: August 30, 2011
Last updated: April 7, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Sleep Apnea, Obstructive
 Procedure: LATERAL PHARYNGOPLASTY

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Pharynx Through MRI in Patients Undergoing Lateral Pharyngoplasty for Treatment of Obstructive Sleep Apnea

Resource links provided by NLM:

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

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

Primary Outcome Measures:
  • expansion of pharynx [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: March 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lateral pharyngoplasty
lateral pharyngoplasty
 Procedure: LATERAL PHARYNGOPLASTY
tonsilectomy and lateral pharyngoplasty

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of obstructive sleep apnea syndrome

Exclusion Criteria:

  • MRI contraindications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427075

Locations
Brazil
Hospital Do Servidor Publico Estadual
Sao Paulo, SP, Brazil
Sponsors and Collaborators
Hospital do Servidor Publico Estadual
Investigators
Principal Investigator: CAROLINA AF VIEIRA, MD Hospital do Servidor Publico Estadual
  More Information

No publications provided

Responsible Party: CAROLINA DE ANDRADE FERREIRA VIEIRA, VIEIRA, CAF, Hospital do Servidor Publico Estadual
ClinicalTrials.gov Identifier: NCT01427075     History of Changes
Other Study ID Numbers: 018/11
Study First Received: August 30, 2011
Last Updated: April 7, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Hospital do Servidor Publico Estadual:
Magnetic Resonance Imaging
Sleep Apnea, Obstructive
Pharyngeal Muscles

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 June 18, 2013