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

NCT ID: NCT01022320

Last Updated: 2009-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-12-31

Brief Summary

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* 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

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The variables are:

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

Conditions

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Obstructive Sleep Apnea High Blood Pressure

Keywords

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OSA Blood pressure Lateral Pharyngoplasty

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgical outcome

20 consecutive cases of patients who underwent the lateral pharyngoplasty

Group Type EXPERIMENTAL

Lateral Pharyngoplasty

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital do Servidor Publico Estadual

OTHER

Sponsor Role lead

Responsible Party

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HSPE

Principal Investigators

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Carolina Soares, MD

Role: PRINCIPAL_INVESTIGATOR

HSPE

Locations

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Hospital do Servidor Estadual de São Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Carolina Soares, MD

Role: CONTACT

Phone: +551184856036

Email: [email protected]

Michel Cahali, MD

Role: CONTACT

Phone: +5088800

Facility Contacts

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Carolina Soares, MD

Role: primary

Michel Cahali, MD

Role: backup

Other Identifiers

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HSPE-001/09

Identifier Type: REGISTRY

Identifier Source: secondary_id

0024.0.338.000-09

Identifier Type: -

Identifier Source: org_study_id