Obstructive Apnea in Patients Submitted to Partial Laryng... | NCT01157286

Studies
Obstructive Apnea in Patients Submitted to Partial Laryngectomy

NCT01157286

Sponsor

Hospital do Servidor Publico Estadual

Status

Unknown status

Last Update Posted

Mar 12, 2018Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

OBSTRUCTIVE SLEEP APNEA

Interventions

Not provided

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

Jul 2010

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

Jun 2010

Primary Completion Date

Jul 2011Estimated

Completion Date

Oct 2011Estimated

First Submitted Date

Jul 6, 2010

First Submission Date that Met QC Criteria

Jul 6, 2010

First Posted Date

Jul 7, 2010Estimated

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

Mar 9, 2018

Last Update Posted Date

Mar 12, 2018Actual

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 investigators intend to study the prevalence of obstructive apnea in patients submitted to partial laryngectomy by larynx cancer. Volunteers will be evaluated using polissonografy. We will try to correlate the residual glotic area with the number of apneas per hour.

Detailed Description

We are trying to avaliate the residual glotic area using spirometry e laryngoscopy

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
level of apnea		patients will be separated depending on the iah(apnea hypopnea index) in mild, moderate and severe

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

PARTIAL LARINGECTOMY, OVER 18 YEARS,

Exclusion Criteria:

TRACHEOSTOMY DEPRESSION USE OF DRUGS SEVERE DPOC CANCER RECURRENCE

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

PATIENTS OVER 18 YEARS, SUBMITED IN THE LAST 15 YEARS TO PARTIAL LARINGECTOMY IFNO TRACHEOSTOMY IS PRESENT

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
RAQUEL C TEIXEIRA, RESIDENT	Contact	55 61 82222073		raquelch@bol.com.br
MICHEL B CAHALI, STAF	Contact	55 11 99519941		mcahali@gmail.com

Overall Officials

Name	Affiliation	Role
raquel teixeira, doctor	HSPE	Principal Investigator
Raquel Teixeira, doctor	pos graduatin student	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto de Assistência Médica ao Servidor Público Estadual	Recruiting	São Paulo		040039901	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

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