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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01455077

Enrollment

Registered

2011-10-19

Start date

2011-01-31

Completion date

2012-01-31

Last updated

2011-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Obstructive Sleep Apnea Syndrome

Keywords

obesity, sleep apnea, portable monitoring

Brief 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.

Interventions

None listed

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* BMI \> 35 * Complaints of snoring, sleep apnea, daytime sleepiness

Exclusion criteria

* use of home oxygen * other sleep diseases * inability to perform PSG

Countries

Brazil

Contacts

Primary ContactLia R Bittencourt, MD, PhD

lia@psicobio.epm.br55 11 21490155

Outcome results