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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04753684
• Other study ID #: 20/45/596
• Status: Completed
• Start date: February 15, 2021
• Est. completion date: October 31, 2021

Study information

• Verified date: January 2021
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: October 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Belgium	UZA	Edegem	Antwerp

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Brigham and Women's Hospital, Harvard Medical School (HMS and HSDM), Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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