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

Obstructive Sleep Apnea Syndrome Clinical Trial

— APOSAS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01210703
• Other study ID #: AcPh.1
• Status: Active, not recruiting
• Phase: N/A
• First received: September 27, 2010
• Last updated: October 14, 2010
• Start date: May 2009
• Est. completion date: December 2010

Study information

• Verified date: September 2010
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age: 18 - 65 years old

• Female and male

Exclusion Criteria:

• Cardiopathies

• Chronic nasal obstruction

• Using neurologic or psychiatric drugs

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Locations

Country	Name	City	State
Brazil	Otolaringology Ambulatory of University of Sao Paulo General Hospital	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil,