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

Obesity Clinical Trial

Official title:

Validation of a Portable Monitoring System for the Diagnosis of Obstructive Sleep Apnea Syndrome in Patients With Level II and III Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01455077
• Other study ID #: CEP0290/11
• Secondary ID: Portable monitor
• Status: Recruiting
• Phase: N/A
• First received: October 15, 2011
• Last updated: October 18, 2011
• Start date: January 2011
• Est. completion date: January 2012

Study information

• Verified date: October 2011
• Source: Associacao Fundo de Incentivo a Psicofarmcologia
• Contact: Lia R Bittencourt, MD, PhD
• Phone: 55 11 21490155
• Email: lia[@]psicobio.epm.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Obesity
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Brazil	Associacao Fundo de Incentivo a Psicofarmacologia	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Associacao Fundo de Incentivo a Psicofarmcologia	Federal University of São Paulo

Country where clinical trial is conducted

Brazil,