Evaluation of Swallowing in Patients With Obstructive Sle... | NCT01335594

Studies
Evaluation of Swallowing in Patients With Obstructive Sleep Apnea

NCT01335594

Sponsor

Luciana Almeida Moreira da Paz Oliveira

Status

Completed

Last Update Posted

Apr 10, 2012Estimated

Enrollment

21Actual

Phase

Not Applicable

Conditions

Sleep Apnea, Obstructive

Interventions

clinical, endoscopical and manometric evaluation

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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Dec 2010Actual

Completion Date

May 2011Actual

First Submitted Date

Apr 11, 2011

First Submission Date that Met QC Criteria

Apr 13, 2011

First Posted Date

Apr 14, 2011Estimated

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

Luciana Almeida Moreira da Paz Oliveira, physician, Hospital do Servidor Publico EstadualSponsor-Investigator

Lead Sponsor

Luciana Almeida Moreira da Paz OliveiraOTHER

Collaborators

Not provided

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 purpose of this study is to test the hypothesis that obstructive sleep apnea syndrome is associated with deviant pharyngeal swallowing function, using clinical, endoscopical and manometric evaluation.

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

21Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
clinical, endoscopical and manometric evaluation	Procedure	clinical evaluation: questionnaire endoscopical analysis manometry

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical evaluation of swallowing in obstructive sleep apnea		within the first 3 months after diagnostic

Secondary Outcomes

Measure	Description	Time Frame
Manometric evaluation of swallowing in obstructive sleep apnea		within the first 3 months after diagnostic
Endoscopic evaluation of swallowing in obstructive sleep apnea		within the first 3 months after diagnostic

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of obstructive sleep apnea syndrome

Exclusion Criteria:

other causes of dysphagia
pharyngeal surgery
prior treatment for obstructive sleep apnea

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luciana A M da Paz Oliveira	Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto de Assistência Médica ao Servidor Público Estadual		São Paulo	São Paulo		Brazil

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive
D003680	Deglutition Disorders

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