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

Primary Purpose

Obstructive Sleep Apnea, High Blood Pressure

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Lateral Pharyngoplasty

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring OSA, Blood pressure, Lateral Pharyngoplasty

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Hospital do Servidor Estadual de São PauloRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surgical outcome

Arm Description

20 consecutive cases of patients who underwent the lateral pharyngoplasty

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01022320

First Posted

November 30, 2009

Last Updated

November 30, 2009

Sponsor

Hospital do Servidor Publico Estadual

1. Study Identification

Unique Protocol Identification Number

NCT01022320

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Unknown status

Study Start Date

May 2009 (undefined)

Primary Completion Date

June 2010 (Anticipated)

Study Completion Date

December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital do Servidor Publico Estadual

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

The variables are: Ambulatory blood pressure data Snoring scale BMI neck circumference abdominal circumference medications and life style changes

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea, High Blood Pressure

Keywords

OSA, Blood pressure, Lateral Pharyngoplasty

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Surgical outcome

Arm Type

Experimental

Arm Description

20 consecutive cases of patients who underwent the lateral pharyngoplasty

Intervention Type

Procedure

Intervention Name(s)

Lateral Pharyngoplasty

Intervention Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Carolina Soares, MD

Phone

+551184856036

naliroca@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Michel Cahali, MD

Phone

+5088800

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carolina Soares, MD

Organizational Affiliation

HSPE

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital do Servidor Estadual de São Paulo

City

São Paulo

ZIP/Postal Code

040000

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carolina Soares, MD

naliroca@hotmail.com

First Name & Middle Initial & Last Name & Degree

Michel Cahali, MD

mcahali@igmail.com

First Name & Middle Initial & Last Name & Degree

Carolina Soares, MD

12. IPD Sharing Statement

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

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