Acoustic Pharyngometry in Obstructive Sleep Apnea Syndrome Patients, With Indication of Continuous Positive Air Pressure (APOSAS)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2010 by University of Sao Paulo General Hospital.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

University of Sao Paulo General Hospital

ClinicalTrials.gov Identifier:

NCT01210703

First received: September 27, 2010

Last updated: October 14, 2010

Last verified: September 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

September 27, 2010

Last Updated Date

October 14, 2010

Start Date ^ICMJE

May 2009

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01210703 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Acoustic Pharyngometry in Obstructive Sleep Apnea Syndrome Patients, With Indication of Continuous Positive Air Pressure

Official Title ^ICMJE

Evaluation of Effect of Continuous Positive Air Pressure (CPAP) on Upper Airway Dimensions, by Acoustic Pharyngometry (AP), in Severe Obstructive Sleep Apnea Syndrome (OSAS) and Primary Snore Patients

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.

Detailed Description

The investigators are performing AP exams in severe apneics (cases) and primary snorers (control group),first basal, and then at the same time of using CPAP with a nasal mask, at progressive pressures (from 4 to 10 cmH20 in snorers, and until 2 pressures above the polysomnography determined pressure in apneics). The wave tube of pharyngometer is connected to the patient´s mouth by a mouthpiece, and to the computer. It makes a graphic of area x distance for each measurement. Then the investigators compare the changes in area, distance and volume of oral cavity and pharynx, determined by CPAP pressures, in both groups, and compare the measurements inside each group and between the two groups. Finally, the investigators analyse the CPAP pressure that most modifies the AP graphic, observing if it has some relationship with the polysomnography determined CPAP pressure.

The investigators intend this way to show the kind of modifies determined by CPAP in oral cavity and oropharynx and, secondarily, observe some relationship of AP and polysomnography in determine the CPAP ideal pressure for severe apneic patients.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability 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).

Condition ^ICMJE

Obstructive Sleep Apnea Syndrome

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age: 18 - 65 years old
Female and male

Exclusion Criteria:

Cardiopathies
Chronic nasal obstruction
Using neurologic or psychiatric drugs

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT01210703

Other Study ID Numbers ^ICMJE

AcPh.1

Has Data Monitoring Committee

Responsible Party

Luiz Ubirajara Sennes, University of Sao Paulo General Hospital

Study Sponsor ^ICMJE

University of Sao Paulo General Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Claudia Inês G de Sousa Silva, Md	University of São Paulo General Hospital
Study Director:	Luiz U Sennes, Phd	University of Sao Paulo General Hospital
Study Director:	Michel B Cahali, Phd	University of Sao Paulo General Hospital

Information Provided By

University of Sao Paulo General Hospital

Verification Date

September 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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