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

NCT04753684 | Completed

• 1 other identifier: 20/45/596
• Study Type: observational
• Target: 181
• Locations: 1 country
• Sites: 1

Brief 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

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

UZA

Edegem, Antwerp, 2650, Belgium

Location

Related Publications (1)

• Op de Beeck S, Vena D, Van de Perck E, Mann D, Azarbarzin A, Alex RM, Dieltjens M, Willemen M, Verbraecken J, Wellman A, Sands SA, Vanderveken OM. Site of Collapse during Drug-induced Sleep Endoscopy Is Associated with Polysomnographic Endotypic Traits: An Observational Study. Ann Am Thorac Soc. 2025 Oct;22(10):1567-1578. doi: 10.1513/AnnalsATS.202408-871OC.

  PMID: 40439552 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: February 15, 2021
• Study Start: February 15, 2021
• Primary Completion: June 30, 2021
• Study Completion: October 31, 2021
• Last Updated: November 30, 2021

Record last verified: 2021-01

Locations

BE (1)