Evaluation Of The Pharynx in Patients Undergoing Lateral Pharyngoplasty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Hospital do Servidor Publico Estadual.
Recruitment status was  Active, not recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014