- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01455077
Portable Monitoring Device for the Diagnosis of Sleep Apnea in Obese Patients
Validation of a Portable Monitoring System for the Diagnosis of Obstructive Sleep Apnea Syndrome in Patients With Level II and III Obesity
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Lia R Bittencourt, MD, PhD
- Phone Number: 55 11 21490155
- Email: lia@psicobio.epm.br
Study Locations
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SP
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São Paulo, SP, Brazil
- Recruiting
- Associacao Fundo de Incentivo a Psicofarmacologia
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Contact:
- Lia R Bittencourt, MD, PhD
- Phone Number: 55 11 21490155
- Email: lia@psicobio.epm.br
-
Contact:
- Erika C Treptow
- Email: erikatpw@hotmail.com
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Sub-Investigator:
- Erika C Treptow
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- BMI > 35
- Complaints of snoring, sleep apnea, daytime sleepiness
Exclusion Criteria:
- use of home oxygen
- other sleep diseases
- inability to perform PSG
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Obese patients
BMI > 35
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Disease
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Signs and Symptoms, Respiratory
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Syndrome
- Obesity
- Apnea
Other Study ID Numbers
- CEP0290/11
- Portable monitoring system for
- STD obesity
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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