Portable Monitoring Device for the Diagnosis of Sleep Apnea in Obese Patients
NCT ID: NCT01455077
Last Updated: 2011-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2011-01-31
2012-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
PROSPECTIVE
Study Groups
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Obese patients
BMI \> 35
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Complaints of snoring, sleep apnea, daytime sleepiness
Exclusion Criteria
* other sleep diseases
* inability to perform PSG
18 Years
80 Years
ALL
Yes
Sponsors
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Federal University of São Paulo
OTHER
Associacao Fundo de Incentivo a Psicofarmcologia
OTHER
Responsible Party
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Prof. Dr. Lia Azeredo-Bittencourt
MD, PhD, associate professor
Locations
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Associacao Fundo de Incentivo a Psicofarmacologia
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Portable monitoring system for
Identifier Type: -
Identifier Source: secondary_id
STD obesity
Identifier Type: -
Identifier Source: secondary_id
CEP0290/11
Identifier Type: -
Identifier Source: org_study_id