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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

September 27, 2010
October 14, 2010
May 2009
December 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01210703 on ClinicalTrials.gov Archive Site
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Acoustic Pharyngometry in Obstructive Sleep Apnea Syndrome Patients, With Indication of Continuous Positive Air Pressure
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

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Probability Sample

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

Obstructive Sleep Apnea Syndrome
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Cardiopathies
  • Chronic nasal obstruction
  • Using neurologic or psychiatric drugs
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01210703
AcPh.1
No
Luiz Ubirajara Sennes, University of Sao Paulo General Hospital
University of Sao Paulo General Hospital
Not Provided
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
University of Sao Paulo General Hospital
September 2010

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