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Correlation Between Upper Airway Endoscopy and Physiological Traits of Obstructive Sleep Apnea

NCT04753684 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 181

Last updated 2021-11-30

No results posted yet for this study

Summary

OBJECTIVES

To train and test a mathematical model to predict complete concentric collapse at the level of the palate (CCCp, primary) and other sites of upper airway collapse (secondary) during drug-induced sleep endoscopy (DISE) using the data captured during a diagnostic polysomnography (PSG).

HYPOTHESIS

The site, pattern and degree of upper airway collapse is associated with distinct flow features as captured during a baseline PSG.

STUDY DESIGN

Retrospective trial.

STUDY POPULATION

200 patients with moderate to severe obstructive sleep apnea (OSA, AHI ≥ 15/h) who underwent both a DISE and a diagnostic PSG at the Antwerp University Hospital (UZA) between January 2018 and December 2020.

OUTCOME MEASURES:

Raw data as captured during a diagnostic PSG, including electroencephalography (EEG), flow, electrocardiography (ECG), electromyography (EMG), oxygen desaturation and breathing effort.

SAMPLE SIZE / DATA ANALYSIS

Data of 200 patients will be retrospectively included into this study protocol. Different machine learning techniques will be adopted to select features, train the model and test the model.

TIME SCHEDULE

January 30, 2021 - November 30, 2021

Conditions

Sponsors & Collaborators

  • Brigham and Women's Hospital

    collaborator OTHER

  • Harvard Medical School (HMS and HSDM)

    collaborator OTHER

  • Universiteit Antwerpen

    collaborator OTHER

  • University Hospital, Antwerp

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-15
Primary Completion
2021-06-30
Completion
2021-10-31

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04753684 on ClinicalTrials.gov