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

NCT01455077 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2011-10-19

No results posted yet for this 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.

Conditions

  • Obstructive Sleep Apnea Syndrome
  • Obesity

Sponsors & Collaborators

  • Federal University of São Paulo

    collaborator OTHER

  • Associacao Fundo de Incentivo a Psicofarmcologia

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-07-31
Completion
2012-01-31

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01455077 on ClinicalTrials.gov