- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01574768
LATERAL PHARYNGOPLASTY OUTCOMES IN THE TREATMENT OF SNORE AND OBSTRUCTIVE SLEEP APNEA
April 7, 2012 updated by: CAROLINA DE ANDRADE FERREIRA VIEIRA, Hospital do Servidor Publico Estadual
The aim of this study is to describe the results of Lateral Pharyngoplasty in the treatment of snore and OSAS.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SP
-
São Paulo, SP, Brazil
- Hospital do Servidor Publico Estadual
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AHI
Time Frame: 6 months
|
Change in AHI
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Michel B Cahali, MD, PhD, University of Sao Paulo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (ANTICIPATED)
August 1, 2012
Study Completion (ANTICIPATED)
September 1, 2012
Study Registration Dates
First Submitted
April 7, 2012
First Submitted That Met QC Criteria
April 7, 2012
First Posted (ESTIMATE)
April 10, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
April 10, 2012
Last Update Submitted That Met QC Criteria
April 7, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 135/11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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