High-resolution Oximetry to Diagnose Obstructive Sleep Apnea

NCT ID: NCT04366193

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-12
• Study Completion Date: 2020-05-30

Brief Summary

The aim of this study was to compare an overnight digital monitoring device (ODM) with home sleep apnea testing (HSAT) using respiratory flow and effort parameters in a large population sample, who were in a waiting list for Polysomnography (PSG).

Detailed Description

Obstructive Sleep Apnea (OSA) is extremely common has prompted the popularization of home sleep test (HST). HST record a limited number of respiratory signals, provide a more comfortable testing option to the patient at a lower cost. HST has a performance as good as PSG among patients with suspected OSA and no significant co-morbidities.

Our study was designed to investigate the performance of a simple solution that consists of a high-resolution wireless oximeter with a built-in accelerometer linked to a smartphone application and automated cloud algorithm for detection of oxygen desaturation, described herein as Overnight Digital Monitoring (ODM) (BilogixTM). We will compare the results of ODM with HST performed by ApneaLink Air by Resmed®.

We have already compared ODM to PSG with excellent results in a prior study and intend to see the results in uncontrolled environment (home) .

Population: Men and women from the São Paulo Department of Health, who are awaiting examination for diagnosis of OSAS.We intend to compare the ODM with the HST. Patients with indication for CPAP titration will be excluded. The participants will wear a wireless oximeter (Oxistar, Biologix Sistemas Ltda., Brazil) with a built-in accelerometer on a finger of the same hand as the HST oximeter and we will compare both methods for diagnosing OSA.

All HST studies will be scored by 2 independent certified technicians blinded to the ODM results. Hypopnea will be defined as a peak signal excursion drop by ≥ 30% of pre-event baseline nasal pressure signal lasting ≥ 10 sec. Hypopneas will be scored according the acceptable AASM criteria for hypopnea (≥ 4% reduction in SpO2). Mild, moderate and severe OSA will be defined according to the current standards (5 ≤ AHI <15; 15 ≤ AHI <30 and AHI ≥30 events/h, respectively).ODI results from ODM will be expressed as the number of desaturations per recording time and will be automatically analyzed at the cloud. In order to compare with TST-AHI4%, ODM will be matched using 4% desaturation criteria (ODM-ODI4%, respectively).

Conditions

Sleep Apnea

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Oximetry

Validation of a high-resolution wireless oximeter for OSA diagnosis comparing with a well established and validated method (home sleep test).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Adult ambulatory patients who are in a waiting list for polysomnography that are able to properly place the oximeter and home sleep test at home

Exclusion Criteria

• patients under treatment for OSA

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Geraldo Lorenzi Filho

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

Pedro R Genta, MD

Role: primary

prgenta@gmail.com

551126625486

Other Identifiers

3767871

Identifier Type: -

Identifier Source: org_study_id