LATERAL PHARYNGOPLASTY OUTCOMES IN THE TREATMENT OF SNORE... | NCT01574768

Studies
LATERAL PHARYNGOPLASTY OUTCOMES IN THE TREATMENT OF SNORE AND OBSTRUCTIVE SLEEP APNEA

NCT01574768

Sponsor

Hospital do Servidor Publico Estadual

Status

Unknown status

Last Update Posted

Apr 10, 2012Estimated

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Snore
Obstructive Sleep Apnea

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

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Aug 2012Estimated

Completion Date

Sep 2012Estimated

First Submitted Date

Apr 7, 2012

First Submission Date that Met QC Criteria

Apr 7, 2012

First Posted Date

Apr 10, 2012Estimated

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

Apr 7, 2012

Last Update Posted Date

Apr 10, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

CAROLINA DE ANDRADE FERREIRA VIEIRA, otolaryngologist, Hospital do Servidor Publico EstadualPrincipal Investigator

Lead Sponsor

Hospital do Servidor Publico EstadualOTHER

Collaborators

Name	Class
University of Sao Paulo	OTHER

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

The aim of this study is to describe the results of Lateral Pharyngoplasty in the treatment of snore and OSAS.

Detailed Description

Not provided

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

300Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lateral Pharyngoplasty	Procedure	Tonsilectomy, microdissection of the superior pharyngeal constrictor muscle within the tonsillar fossa and sectioning of this muscle

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AHI	Change in AHI	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michel B Cahali, MD, PhD	University of Sao Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital do Servidor Público Estadual		São Paulo	São Paulo		Brazil

Condition Browse Module

MeSH Terms

ID	Term
D012913	Snoring
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012135	Respiratory Sounds
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided