CClinicalTrials.gg
Status unknownNCT01210703APOSASUpdated Oct 15, 2010

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

An observational study in Obstructive Sleep Apnea Syndrome, sponsored by University of Sao Paulo General Hospital. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-10-15.

Sponsored by University of Sao Paulo General Hospital · Observational

The sponsor has not verified this record recently (last verified Sep 2010), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
50
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Obstructive Sleep Apnea Syndrome

Keywords

  • Acoustic Pharyngometry
  • CPAP
  • Obstructive Sleep Apnea Syndrome
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In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's planned enrollment of 50 is below the median of 106 across 386 observational studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
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).

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
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Study locations

1 site
  • Otolaringology Ambulatory of University of Sao Paulo General Hospital
    Sao Paulo, 04119061, Brazil
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01210703
Lead sponsor
University of Sao Paulo General Hospital
First posted
Sep 28, 2010
Start date
May 2009
Primary completion
Dec 2010 (estimated)
Completion
Dec 2010 (estimated)
Last update
Oct 15, 2010

Study contacts

Claudia Inês G de Sousa Silva, Md
principal investigator · University of São Paulo General Hospital
Luiz U Sennes, Phd
study director · University of Sao Paulo General Hospital
Michel B Cahali, Phd
study director · University of Sao Paulo General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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