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LATERAL PHARYNGOPLASTY OUTCOMES IN THE TREATMENT OF SNORE AND OBSTRUCTIVE SLEEP APNEA

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ClinicalTrials.gov Identifier: NCT01574768
Recruitment Status : Unknown
Verified April 2012 by CAROLINA DE ANDRADE FERREIRA VIEIRA, Hospital do Servidor Publico Estadual.
Recruitment status was:  Active, not recruiting
First Posted : April 10, 2012
Last Update Posted : April 10, 2012
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
CAROLINA DE ANDRADE FERREIRA VIEIRA, Hospital do Servidor Publico Estadual

Brief Summary:
The aim of this study is to describe the results of Lateral Pharyngoplasty in the treatment of snore and OSAS.

Condition or disease Intervention/treatment Phase
Snore Obstructive Sleep Apnea Procedure: Lateral Pharyngoplasty Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LATERAL PHARYNGOPLASTY OUTCOMES IN THE TREATMENT OF SNORE AND OBSTRUCTIVE SLEEP APNEA
Study Start Date : November 2011
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea Snoring


Intervention Details:
  • Procedure: Lateral Pharyngoplasty
    Tonsilectomy, microdissection of the superior pharyngeal constrictor muscle within the tonsillar fossa and sectioning of this muscle


Primary Outcome Measures :
  1. AHI [ Time Frame: 6 months ]
    Change in AHI



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • snore
  • osas

Exclusion Criteria:

  • previous pharynx surgery
  • use of medication that modifies the muscular tonus or the perception of sleepiness before or after the surgery
  • body mass index (BMI) bigger than 35 kg/m2
  • neurological or psychiatric disease.

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): NCT01574768


Locations
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Brazil
Hospital do Servidor Público Estadual
São Paulo, SP, Brazil
Sponsors and Collaborators
Hospital do Servidor Publico Estadual
University of Sao Paulo
Investigators
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Principal Investigator: Michel B Cahali, MD, PhD University of Sao Paulo
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Responsible Party: CAROLINA DE ANDRADE FERREIRA VIEIRA, otolaryngologist, Hospital do Servidor Publico Estadual
ClinicalTrials.gov Identifier: NCT01574768    
Other Study ID Numbers: 135/11
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: April 10, 2012
Last Verified: April 2012
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases