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Completed

NCT Number: NCT03526133

Validation of Sleep Apnea Diagnosis Device

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.

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Key information

Conditions

Sleep Apnea Apnea Dyssomnias Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Snoring

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Incor - Heart Institute, Sleep Laboratory

São Paulo, 05403-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • polysomnography for the CPAP titration

Treatment and study plan

Polysomnography (PSG) and wireless sensor Oxistar

Diagnostic Test

Monitoring the apnea-hypopnea index (AHI) derived from PSG and the oxygen desaturation index (ODI) obtained by the Oxistar.

Primary outcomes

  1. Sensitivity

    Time frame: Night during the polysomnography exam

    Sensitivity of Oxistar device to detect apnea events compared to gold-standard polysomnography

  2. Specificity

    Time frame: Night during the polysomnography exam

    Specificity of Oxistar device to detect apnea events compared to gold-standard polysomnography

  3. Area under the curve (AUC)

    Time frame: Night during the polysomnography exam

    AUC from ROC curves reflects the accuracy of Oxistar device to detect apnea events compared to gold-standard polysomnography

  4. Bland-Altman Graph

    Time frame: Night during the polysomnography exam

    The Bland-Altman graph evaluates the "agreement" between the gold-standard polysomnography and Oxistar device

  5. Interclass Correlation Coefficient (ICC)

    Time frame: Night during the polysomnography exam

    ICC measures the reliability of measurements or ratings between the gold-standard polysomnography and Oxistar device

Secondary outcomes

  1. Sleep Actigraphy

    Time frame: Night during the polysomnography exam

    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)

  2. Number of snoring events per hour of register (snoring/h)

    Time frame: Night during the polysomnography exam

    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).

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Biologix Sistemas Ltda

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
May 16, 2018
Registry last updated
Sep 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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