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Status unknownNCT01455077Updated Oct 19, 2011

Portable Monitoring Device for the Diagnosis of Sleep Apnea in Obese Patients

An observational study in Obstructive Sleep Apnea Syndrome and Obesity, sponsored by Associacao Fundo de Incentivo a Psicofarmcologia. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-10-19.

Sponsored by Associacao Fundo de Incentivo a Psicofarmcologia · Observational

The sponsor has not verified this record recently (last verified Oct 2011), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Introduction The portable monitoring system (PMS) recording of cardiopulmonary parameters (level III of ASDA) has been validated in subjects with high probability of Obstructive Sleep Apnea (OSA) without comorbidities.

However, there is not any study evaluating this system when OSA is associated with morbid obesity, so the validation of PMS will be very useful in order to properly work-up this highly risk population.

Objective:

To evaluate the accuracy of level III type of PMS - Stardust™" (STD), on patients with level II and III of obesity and high clinical suspicion of OSA.

Methods:Participants with BMI > 35 kg/m2 and with suspicion of OSA will consecutively be selected from an Outpatients Sleep Clinic of UNIFESP. They will be randomized for the following order of recordings:

  1. STD at home for 1 night 2) STD in the sleep lab simultaneous to PSG. AHI will be taken for subsequent analysis:a) AHI PSG b) AHI STD -lab and c) AHI STD- home.
02

Conditions studied

  • Obstructive Sleep Apnea Syndrome
  • Obesity

Keywords

  • obesity
  • sleep apnea
  • portable monitoring
03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 160 are open to participants now.

This study's planned enrollment of 40 is below the median of 106 across 386 observational studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

Associacao Fundo de Incentivo a Psicofarmcologia is the lead sponsor of 8 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Adults BMI > 35 Male and female

Inclusion criteria

  • BMI > 35
  • Complaints of snoring, sleep apnea, daytime sleepiness

Exclusion criteria

Exclusion Criteria:

  • use of home oxygen
  • other sleep diseases
  • inability to perform PSG
05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
40 participants (estimated)

Groups and cohorts

  • Obese patients

    BMI \> 35

06

Study locations

1 of 1 sites recruiting
  • Associacao Fundo de Incentivo a Psicofarmacologia
    São Paulo, SP, Brazil
    Recruiting
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01455077
Lead sponsor
Associacao Fundo de Incentivo a Psicofarmcologia
Collaborators
Federal University of São Paulo
Responsible party
Prof. Dr. Lia Azeredo-Bittencourt (MD, PhD, associate professor, Associacao Fundo de Incentivo a Psicofarmcologia) — Principal investigator
First posted
Oct 19, 2011
Start date
Jan 2011
Primary completion
Jul 2011
Completion
Jan 2012 (estimated)
Last update
Oct 19, 2011

Study contacts

Lia R Bittencourt, MD, PhD
Contact
lia@psicobio.epm.br
55 11 21490155

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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