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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by Associacao Fundo de Incentivo a Psicofarmcologia.
Recruitment status was:  Recruiting
Federal University of São Paulo
Information provided by (Responsible Party):
Prof. Dr. Lia Azeredo-Bittencourt, Associacao Fundo de Incentivo a Psicofarmcologia Identifier:
First received: October 15, 2011
Last updated: October 18, 2011
Last verified: October 2011

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.


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.

Obstructive Sleep Apnea Syndrome

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Validation of a Portable Monitoring System for the Diagnosis of Obstructive Sleep Apnea Syndrome in Patients With Level II and III Obesity

Resource links provided by NLM:

Further study details as provided by Associacao Fundo de Incentivo a Psicofarmcologia:

Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: January 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Obese patients
BMI > 35


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   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:

  • use of home oxygen
  • other sleep diseases
  • inability to perform PSG
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01455077

Contact: Lia R Bittencourt, MD, PhD 55 11 21490155

Associacao Fundo de Incentivo a Psicofarmacologia Recruiting
São Paulo, SP, Brazil
Contact: Lia R Bittencourt, MD, PhD    55 11 21490155   
Contact: Erika C Treptow   
Sub-Investigator: Erika C Treptow         
Sponsors and Collaborators
Associacao Fundo de Incentivo a Psicofarmcologia
Federal University of São Paulo
  More Information

Responsible Party: Prof. Dr. Lia Azeredo-Bittencourt, MD, PhD, associate professor, Associacao Fundo de Incentivo a Psicofarmcologia Identifier: NCT01455077     History of Changes
Other Study ID Numbers: CEP0290/11
Portable monitoring system for
STD obesity
Study First Received: October 15, 2011
Last Updated: October 18, 2011

Keywords provided by Associacao Fundo de Incentivo a Psicofarmcologia:
sleep apnea
portable monitoring

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Pathologic Processes
Nutrition Disorders
Body Weight
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases processed this record on May 23, 2017