Portable Monitoring Device for the Diagnosis of Sleep Apnea in Obese Patients
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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 |
| 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 |
Adults BMI > 35 Male and female
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| Contact: Lia R Bittencourt, MD, PhD | 55 11 21490155 | lia@psicobio.epm.br |
| 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 | |
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:
|
Apnea Obesity Sleep Apnea Syndromes Sleep Apnea, Obstructive 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 May 19, 2013