Effect of Lateral Pharyngoplasty on Blood Pressure in Obstructive Sleep Apnea (OSA) Patients

November 30, 2009 updated by: Hospital do Servidor Publico Estadual

Effect of Lateral Pharyngoplasty on Blood Pressure in Obstructive Sleep Apnea Patients

  • Describe blood pressure changes on patients with OSA treated with lateral pharyngoplasty
  • Compare the mean of systolic and diastolic blood pressure in 24 hours, average systolic and diastolic pressure during daytime and night and changes in the nocturnal decrease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The variables are:

Ambulatory blood pressure data Snoring scale BMI neck circumference abdominal circumference medications and life style changes

Study Type

Interventional

Enrollment (Anticipated)

20

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 Contact

Study Contact Backup

  • Name: Michel Cahali, MD
  • Phone Number: +5088800

Study Locations

  • Brazil
      • São Paulo, Brazil, 040000
        • Recruiting
        • Hospital do Servidor Estadual de São Paulo
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carolina Soares, MD

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult Patient
  • BMI < 35
  • no Benzodiazepinec User

Exclusion Criteria:

  • BMI > 35
  • Use of benzodiazepinecs
  • Clinical contra-indications to surgery (ASA III or ASA IV)

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgical outcome
20 consecutive cases of patients who underwent the lateral pharyngoplasty
Procedure: Lateral Pharyngoplasty
surgery lateral pharyngoplasty: consists on the section and rotation of the superior constrictor pharyngeal muscle associated with the ressection of the palatopharyngeus preserving the palatoglossus and mucosa of posterior and anterior tonsilar pillar , bilaterally.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital do Servidor Publico Estadual

Investigators

  • Principal Investigator: Carolina Soares, MD, HSPE

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

May 1, 2009

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

November 30, 2009

First Submitted That Met QC Criteria

November 30, 2009

First Posted (Estimate)

December 1, 2009

Study Record Updates

Last Update Posted (Estimate)

December 1, 2009

Last Update Submitted That Met QC Criteria

November 30, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0024.0.338.000-09
  • HSPE-001/09 (Registry Identifier: Otorhinolaryngology department of HSPE)

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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