COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

LATERAL PHARYNGOPLASTY OUTCOMES IN THE TREATMENT OF SNORE AND 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: 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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
Brazil
Hospital do Servidor Público Estadual
São Paulo, SP, Brazil
Sponsors and Collaborators
Hospital do Servidor Publico Estadual
University of Sao Paulo
Investigators
Layout table for investigator information
Principal Investigator: Michel B Cahali, MD, PhD University of Sao Paulo
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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:
Layout table for MeSH terms
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