NCT01210703

Brief Summary

Acoustic Pharyngometry (AP) is a method of measurement of Transversal Sectional Areas (TSA) and Volumes of oral cavity and pharynx, based on acoustic waves. The aim of this study is to describe changes on oropharynx dimensions caused by CPAP (Continuous Positive Air Pressure) in patients with severe Obstructive Sleep Apnea Syndrome when compared with patients with Primary Snore, using AP. The exam will be made during the use of CPAP, at various pressures. The investigators also intend to determine if pressure determined by Polysomnography in OSAS patients cause some type of different change in AP graphic.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 15, 2010

Status Verified

September 1, 2010

Enrollment Period

1.6 years

First QC Date

September 27, 2010

Last Update Submit

October 14, 2010

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

Acoustic PharyngometryCPAPObstructive Sleep Apnea Syndrome

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Severe Sleep Obstructive Apnea Syndrome and Primary Snorers, who have already made a polysomnography (in apneics, polysomnography for CPAP titulation, too).

You may qualify if:

  • Age: 18 - 65 years old
  • Female and male

You may not qualify if:

  • Cardiopathies
  • Chronic nasal obstruction
  • Using neurologic or psychiatric drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Otolaringology Ambulatory of University of Sao Paulo General Hospital

São Paulo, São Paulo, 04119061, Brazil

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Claudia Inês G de Sousa Silva, Md

    University of São Paulo General Hospital

    PRINCIPAL INVESTIGATOR

  • Luiz U Sennes, Phd

    University of Sao Paulo General Hospital

    STUDY DIRECTOR

  • Michel B Cahali, Phd

    University of Sao Paulo General Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 27, 2010

First Posted

September 28, 2010

Study Start

May 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

October 15, 2010

Record last verified: 2010-09

Locations

BR(1)