Validation of Sleep Apnea Diagnosis Device

Validation of a Wireless Wearable Sensor Using Mobile Technology and Cloud Computing for the Diagnosis of Sleep Apnea

Obstructive sleep apnea (OSA) is common and largely underdiagnosed disease. The standard method for the diagnosis of OSA is a complete night polysomnography (PSG). Simple methods for OSA diagnosis are necessary. The overnight oximetry with the oxygen desaturation index (ODI) has been largely investigated as a diagnostic test for OSA but its accuracy remains undefined. The aim of our study is to evaluate if an wireless polygraph (Oxistar) is accurate to diagnosis OSA in patients referred to a Sleep Lab.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea
• Intervention / Treatment: Diagnostic test: Polysomnography (PSG) and wireless sensor Oxistar

Detailed Description

Consecutive patients referred to the sleep laboratory with suspected diagnosis of OSA underwent in-laboratory polysomnography (PSG) and simultaneously wireless polygraph. The PSG oximeter and the wireless polygraph were worn on different fingers of the same hand. All sleep studies were reviewed by one blind investigator according the 2017 American Academy of Sleep Medicine recommendations. The number of desaturations from wireless polygraph at the 3 predefined threshold levels (of ODI-2%, ODI-3%, or ODI-4%) was derived automatically using proprietary algorithm. Moderate to severe OSA was defined as AHI ≥ 15 events/h. The diagnostic accuracy of ODI-2%, 3%, and 4% for the diagnosis of moderate-severe OSA were calculated for cut-off values from 1 to 20 desaturation events/h. The sleep actimetry was compared with the sleep stages from PSG, most of the statistical metrics applied for diagnosis were used to evaluate the applicability of this proposed method. Finally, the snoring events computed by the smartphone application were compared with the events heard by a specialist and the statistical comparison metrics were evaluated.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403-900
    • Incor - Heart Institute, Sleep Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients referred to a university-based tertiary sleep referral centre.

Description

Inclusion Criteria:

• referred by medical staff for an overnight assessment for suspected sleep apnea

Exclusion Criteria:

• polysomnography for the CPAP titration

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	Sensitivity of Oxistar device to detect apnea events compared to gold-standard polysomnography	Night during the polysomnography exam
Specificity	Specificity of Oxistar device to detect apnea events compared to gold-standard polysomnography	Night during the polysomnography exam
Area under the curve (AUC)	AUC from ROC curves reflects the accuracy of Oxistar device to detect apnea events compared to gold-standard polysomnography	Night during the polysomnography exam
Bland-Altman Graph	The Bland-Altman graph evaluates the "agreement" between the gold-standard polysomnography and Oxistar device	Night during the polysomnography exam
Interclass Correlation Coefficient (ICC)	ICC measures the reliability of measurements or ratings between the gold-standard polysomnography and Oxistar device	Night during the polysomnography exam

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Actigraphy	Actigraphy is the continuous measurement of activity or movement with the use of a small device called an actigraph. Periods of movement suggest wakefulness while those of relative stillness would likely correspond to sleep or quiescence. The Oxistar has a embeded actigraph whose data will be compared with the sleep stage scoring from polysomnography (PSG), the gold standard for sleep assessment. Epoch-by-epoch (30 seconds) agreement between the actigraph and PSG will be assessed by calculating sensitivity, specificity, accuracy, area under the curve (AUC), Bland-Altman graph and interclass correlation coefficient (ICC)	Night during the polysomnography exam
Number of snoring events per hour of register (snoring/h)	Snoring is one of the signs suggestive of obstructive sleep apnea and has recently been considered as having great diagnostic potential. The smartphone application (app) through microphone performs the recording and the characteristics extraction of the patient's audio during sleep (register time). A multilayer perceptron (MPL) neural network classifies the event as snoring or non-snoring. Lastly, the amount of snoring occured is accounted and divided by the register time leading to the number of snoring/h. The agreement between snoring/h measured by the app and the heard by a specialist will be assessed by calculating sensitivity, specificity, accuracy and area under the curve (AUC).	Night during the polysomnography exam

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Biologix Sistemas Ltda
• Investigators: Principal Investigator: Geraldo Lorenzi-Filho, MD, PhD, Associate Professor

Publications and helpful links

General Publications

• Pinheiro GDL, Cruz AF, Domingues DM, Genta PR, Drager LF, Strollo PJ, Lorenzi-Filho G. Validation of an Overnight Wireless High-Resolution Oximeter plus Cloud-Based Algorithm for the Diagnosis of Obstructive Sleep Apnea. Clinics (Sao Paulo). 2020 Nov 27;75:e2414. doi: 10.6061/clinics/2020/e2414. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2017
• Primary Completion (Actual): December 7, 2018
• Study Completion (Actual): February 7, 2019

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: May 3, 2018
• First Posted (Actual): May 16, 2018

Study Record Updates

• Last Update Posted (Actual): September 30, 2019
• Last Update Submitted That Met QC Criteria: September 27, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: snoring; sleep apnea; portable monitor; polygraph; home sleep apnea test (HSAT); apnea hypopnea index (AHI); oxygen desaturation index (ODI); sleep actimetry
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Apnea
• Other Study ID Numbers: 70485317.0.0000.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No