Obstructive Sleep ApneaNCT04753684
Correlation Between Upper Airway Endoscopy and Physiological Traits of Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea, run by University Hospital, Antwerp at 1 site in Belgium.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 181 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Feb 2021to 31 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with moderate to severe OSA who underwent polysomnography and DISE at UZA in the last 3 years.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read more
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
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Retrospective, measured during the baseline polysomnography study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start15 Feb 2021
- Primary completion30 Jun 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Harvard Medical School (HMS and HSDM), Universiteit Antwerpen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753684
- Sponsor's protocol ID
- 20/45/596
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40439552
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Upper Airway Endoscopy and Physiological Traits of Obstructive Sleep Apnea: a Retrospective Study
- ClinicalTrials.gov ID
- NCT04753684
- Acronym / sponsor ID
- 20/45/596
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Harvard Medical School (HMS and HSDM), Universiteit Antwerpen
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate to severe OSA who underwent polysomnography and DISE at UZA in the last 3 years.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Airflow [l/s]
Time frame: Retrospective, measured during the baseline polysomnography study
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Derived from this study: PubMed 40439552Op 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.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
Sleep Apnea, Obstructive, Sleep Staging
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Enrolling by invitation
Myofunctional Therapy for Obstructive Sleep Apnea
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Airflow [l/s] (time frame: Retrospective, measured during the baseline polysomnography study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04753684, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.