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

Correlation Between Upper Airway Endoscopy and Physiological Traits of Obstructive Sleep Apnea: a Retrospective Study

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

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea

• Study Type: Observational
• Enrollment (Actual): 181

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • UZA

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate to severe OSA who underwent polysomnography and DISE at UZA in the last 3 years.

Description

Inclusion Criteria:

• 18 years or older.
• Diagnosis with symptomatic moderate to severe OSA (AHI ≥ 15/h).
• Underwent DISE at UZA as part of the clinical pathway for non-continuous positive airway pressure (CPAP) therapies
• Underwent a baseline diagnostic PSG at UZA max 2 years before DISE

Exclusion Criteria:

• Medication use related to sleeping disorders
• Central Sleep Apnea Syndrome.
• Medical history of known causes of tiredness by day or severe sleep disruption (insomnia, periodic leg movements, narcolepsy).
• Seizure disorder.
• Known medical history of intellectual disability, memory disorders or current psychiatric disorders (psychotic illness, major depression, or acute anxiety attacks as mentioned by the patient).
• Pregnancy
• <4 h of data recording during the baseline PSG night

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Airflow [l/s]	The primary outcome of this study is the effect of DISE site, degree and pattern of collapse on the airflow [l/s] as measured during the baseline polysomnography	Retrospective, measured during the baseline polysomnography study

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Collaborators: Harvard Medical School (HMS and HSDM); Brigham and Women's Hospital; Universiteit Antwerpen

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• 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; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 20/45/596

Drug and device information, study documents

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