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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 Prof. Dr. Lia Azeredo-Bittencourt, Associacao Fundo de Incentivo a Psicofarmcologia.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01455077
First Posted: October 19, 2011
Last Update Posted: October 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Federal University of São Paulo
Information provided by (Responsible Party):
Prof. Dr. Lia Azeredo-Bittencourt, Associacao Fundo de Incentivo a Psicofarmcologia
  Purpose

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.


Condition
Obstructive Sleep Apnea Syndrome Obesity

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 Prof. Dr. Lia Azeredo-Bittencourt, 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)
Groups/Cohorts
Obese patients
BMI > 35

  Eligibility

Information from the National Library of Medicine

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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
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01455077


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

Locations
Brazil
Associacao Fundo de Incentivo a Psicofarmacologia Recruiting
São Paulo, SP, Brazil
Contact: Lia R Bittencourt, MD, PhD    55 11 21490155    lia@psicobio.epm.br   
Contact: Erika C Treptow       erikatpw@hotmail.com   
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
ClinicalTrials.gov Identifier: NCT01455077     History of Changes
Other Study ID Numbers: CEP0290/11
Portable monitoring system for
STD obesity
First Submitted: October 15, 2011
First Posted: October 19, 2011
Last Update Posted: October 19, 2011
Last Verified: October 2011

Keywords provided by Prof. Dr. Lia Azeredo-Bittencourt, Associacao Fundo de Incentivo a Psicofarmcologia:
obesity
sleep apnea
portable monitoring

Additional relevant MeSH terms:
Syndrome
Obesity
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Disease
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases