NCT01335594

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2010

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

February 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 14, 2011

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

April 10, 2012

Status Verified

April 1, 2012

Enrollment Period

10 months

First QC Date

April 11, 2011

Last Update Submit

April 7, 2012

Conditions

Sleep Apnea, Obstructive

Keywords

Sleep apnea, obstructiveDeglutition DisordersManometryEndoscopy

Outcome Measures

Primary Outcomes (1)

  • Clinical evaluation of swallowing in obstructive sleep apnea

    within the first 3 months after diagnostic

Secondary Outcomes (2)

  • 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

Interventions

clinical, endoscopical and manometric evaluationPROCEDURE

clinical evaluation: questionnaire endoscopical analysis manometry

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of obstructive sleep apnea syndrome

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Assistência Médica ao Servidor Público Estadual

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveDeglutition Disorders

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Luciana A M da Paz Oliveira

    Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
physician

Study Record Dates

First Submitted

April 11, 2011

First Posted

April 14, 2011

Study Start

February 1, 2010

Primary Completion

December 1, 2010

Study Completion

May 1, 2011

Last Updated

April 10, 2012

Record last verified: 2012-04

Locations

BR(1)