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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Associacao Fundo de Incentivo a Psicofarmcologia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Federal University of São Paulo
Information provided by (Responsible Party):
Prof. Dr. Lia Azeredo-Bittencourt, Associacao Fundo de Incentivo a Psicofarmcologia
ClinicalTrials.gov Identifier:
NCT01455077
First received: October 15, 2011
Last updated: October 18, 2011
Last verified: October 2011
  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 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 15, 2011
Last Updated: October 18, 2011
Health Authority: Brazil: National Committee of Ethics in Research

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

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

ClinicalTrials.gov processed this record on July 26, 2014