Correlation Between Upper Airway Endoscopy and Physiologi... | NCT04753684

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

NCT04753684

Sponsor

University Hospital, Antwerp

Status

Completed

Last Update Posted

Nov 30, 2021Actual

Enrollment

181Actual

Phase

Not provided

Conditions

Obstructive Sleep Apnea

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2021Actual

Primary Completion Date

Jun 30, 2021Actual

Completion Date

Oct 31, 2021Actual

First Submitted Date

Jan 11, 2021

First Submission Date that Met QC Criteria

Feb 10, 2021

First Posted Date

Feb 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2021

Last Update Posted Date

Nov 30, 2021Actual

Name	Class
Brigham and Women's Hospital	OTHER
Harvard Medical School (HMS and HSDM)	OTHER
Universiteit Antwerpen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

181Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
UZA		Edegem	Antwerp	2650	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40439552	Derived	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.

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases