Back to resultsLATERAL PHARYNGOPLASTY OUTCOMES IN THE TREATMENT OF SNORE AND OBSTRUCTIVE SLEEP APNEA
Primary Purpose
Snore, Obstructive Sleep Apnea
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Lateral Pharyngoplasty
Sponsored by
About this trial
This is an interventional treatment trial for Snore
Eligibility 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.
Sites / Locations
- Hospital do Servidor Público Estadual
Outcomes
Primary Outcome Measures
AHI
Change in AHI
Secondary Outcome Measures
Full Information
NCT ID
NCT01574768
First Posted
April 7, 2012
Last Updated
April 7, 2012
Sponsor
Hospital do Servidor Publico Estadual
Collaborators
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01574768
Brief Title
LATERAL PHARYNGOPLASTY OUTCOMES IN THE TREATMENT OF SNORE AND OBSTRUCTIVE SLEEP APNEA
Official Title
LATERAL PHARYNGOPLASTY OUTCOMES IN THE TREATMENT OF SNORE AND OBSTRUCTIVE SLEEP APNEA
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital do Servidor Publico Estadual
Collaborators
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to describe the results of Lateral Pharyngoplasty in the treatment of snore and OSAS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snore, Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Lateral Pharyngoplasty
Intervention Description
Tonsilectomy, microdissection of the superior pharyngeal constrictor muscle within the tonsillar fossa and sectioning of this muscle
Primary Outcome Measure Information:
Title
AHI
Description
Change in AHI
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel B Cahali, MD, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital do Servidor Público Estadual
City
São Paulo
State/Province
SP
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
LATERAL PHARYNGOPLASTY OUTCOMES IN THE TREATMENT OF SNORE AND OBSTRUCTIVE SLEEP APNEA
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