search
Back to results

LATERAL 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
Hospital do Servidor Publico Estadual
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Snore

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 7, 2012
Last Updated
April 7, 2012
Sponsor
Hospital do Servidor Publico Estadual
Collaborators
University of Sao Paulo
search

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

We'll reach out to this number within 24 hrs