NCT01576926

Brief Summary

Evolution of swallowing in patients undergoing lateral pharyngoplasty with preservation stylopharyngeal muscle.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 13, 2012

Completed
Last Updated

April 13, 2012

Status Verified

April 1, 2012

Enrollment Period

2.3 years

First QC Date

April 9, 2012

Last Update Submit

April 11, 2012

Conditions

Sleep Apnea

Keywords

Sleep apnea, obstructiveDeglutition Disorders

Outcome Measures

Primary Outcomes (1)

  • Evolution of swallowing in patients undergoing lateral pharyngoplasty with preservation stylopharyngeal muscle

    refer patients with oas to the side faringolastia with total preservation stylopharyngeal muscle and evaluate recovery time of swallowing during 30 days.

    assess progress daily until the end of swallowing dysphagia during 30 days

Secondary Outcomes (1)

  • Evolution of swallowing in patients undergoing lateral pharyngoplasty with preservation stylopharyngeal muscle

    assess progress daily until the end of swallowing dysphagia during 30 days

Study Arms (1)

surgery

patients with obstructive sleep apnea

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with obstructive sleep apnea, indicating the lateral pharyngeal

You may qualify if:

  • patients with obstructive sleep apnea with surgical indication

You may not qualify if:

  • patients with obstructive sleep apnea without surgical indication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Do Servidor Publico Estadual

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesSleep Apnea, ObstructiveDeglutition Disorders

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Jayson Mesti, medical

    Hopital Do Servidor Público Estadual

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
evolution of swallowing in patients undergoing lateral pharyngoplasty

Study Record Dates

First Submitted

April 9, 2012

First Posted

April 13, 2012

Study Start

March 1, 2009

Primary Completion

June 1, 2011

Study Completion

February 1, 2012

Last Updated

April 13, 2012

Record last verified: 2012-04

Locations

BR(1)