Effect of Lateral Pharyngoplasty on Blood Pressure in Obs... | NCT01022320

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

NCT01022320

Sponsor

Hospital do Servidor Publico Estadual

Status

Unknown status

Last Update Posted

Dec 1, 2009Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea
High Blood Pressure

Interventions

Lateral Pharyngoplasty

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
HSPE-001/09	Registry Identifier	Otorhinolaryngology department of HSPE

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Jun 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Nov 30, 2009

First Submission Date that Met QC Criteria

Nov 30, 2009

First Posted Date

Dec 1, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2009

Last Update Posted Date

Dec 1, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgical outcome	Experimental	20 consecutive cases of patients who underwent the lateral pharyngoplasty	Procedure: Lateral Pharyngoplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lateral Pharyngoplasty	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.

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Carolina Soares, MD	Contact	+551184856036		naliroca@hotmail.com
Michel Cahali, MD	Contact	+5088800

Overall Officials

Name	Affiliation	Role
Carolina Soares, MD	HSPE	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital do Servidor Estadual de São Paulo	Recruiting	São Paulo	São Paulo	040000	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive
D006973	Hypertension

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided