Obstructive Sleep ApneaNCT05267808
Pathophysiological Endotyping Using Baseline Polysomnography Data
An observational study of Obstructive Sleep Apnea, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
The study is designed to develop models to predict site of collapse information using routine polysomnography. In an observational study, the investigators will study 1000 patients with obstructive sleep apnea (OSA) who have had a recent polysomnographic study and will undergo drug-induced sleep endoscopy (DISE) as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Drug-induced sleep endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2022to Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 diagnosed obstructive sleep apnea, who are eligible for drug-induced sleep endoscopy (DISE) as the next step in their clinical path.
Who may be able to join
- 18 years or older.
- Diagnosis with OSA (AHI ≥ 5).
- Eligible for drug-induced sleep endoscopy as the next step in the clinical path for OSA.
- Capable of giving informed consent.
Who cannot join
- Diagnostic polysomnography data not available at the Antwerp University Hospital.
- Factors indicative of unstable clinical status or would preclude DISE investigation:
- Medication use related to sleeping disorders.
- Central Sleep Apnea Syndrome.
- Medical history of known causes of tiredness by day or severe sleep disruption (insomnia, PLMS, Narcolepsy).
- Seizure disorders.
- 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 or willing to become pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Antwerp University Hospital
Edegem, 2650
Olivier M Vanderveken, MD, PhD
About this study
Official title: Prediction of Drug-Induced Sleep Endoscopy Outcome From Baseline Diagnostic Data Including Polysomnography
The study is designed to develop models to predict site of collapse information using routine polysomnography. In an observational study, the investigators will study 1000 patients with obstructive sleep apnea (OSA) who have had a recent polysomnographic study and will undergo drug-induced sleep endoscopy (DISE) as part of their standard clinical care. Flow shape information from the polysomnographic study will be associated with the DISE results, and a set of prediction models will be developed and validated to detect the site, pattern and degree of upper airway collapse as seen during DISE.
Read the detailed description
The site, pattern and degree of upper airway collapse is associated with the outcome of different OSA therapies. In current clinical practice, this information is assessed during DISE, in which the upper airway is evaluated during a light sedation, mimicking natural sleep. Information on the site of collapse is not currently available from routine clinical sleep studies.
Recent research has shown that the site of upper airway collapse seen during endoscopy can be recognized from the distinct airflow shape patterns. For example, greater "negative effort dependence" (NED) or inspiratory scooping is associated with non-tongue-base sites of collapse. In preliminary analysis using >150 patients, the investigators recently developed a logistic regression model predicting complete concentric collapse at the level of the palate (CCCp). The model included 6 meaningful airflow features (scoopiness NED, inspiratory skewness, peak flow in early inspiration, inspiratory volume in the first 3rd of inspiration, inspiratory rise time, peak volume). Each feature is calculated as the mean value during identified hypopneas. Other sites of collapse were also assessed using the same six features in separate models (lateral walls, tongue-base, epiglottis).
The study will proceed in two phases of development. In the first phase, the investigators will prospectively validate the preliminary model for predictive CCCP in 300 patients (primary outcome test for phase I). Odds for true CCCP in the predicted CCCP subgroup will be compared against the odds for CCCP in the predicted non-CCCP subgroup (Fisher exact test). Secondary analyses will validate the other three model (lateral walls, tongue-base, epiglottis).
Prior to the second phase, the investigators will develop a refined model to predict CCCP using all available pooled data (N>450). The investigators will seek to include new parameters or incorporate additional interactions between predictors, where appropriate, Refined models for other sites will also be developed. Sensitivity analyses will examine different patterns of collapse (e.g. anterior-posterior), different severities (partial vs complete), how to optimally account for multi-site obstruction, and whether predicted sites are correlated.
In the second phase, the investigators will prospectively apply the refined model to N=700 patients, following the same analytic approach as for phase 1.
Interim analysis will be performed but the study will not be terminated for early success).
Patients will undergo therapies per clinical indication and will be documented; In the entire dataset, the investigators will explore whether the presence of CCCP (per model prediction, and per DISE results) is associated with reduced efficacy of oral appliances, hypoglossal nerve stimulation, positional therapy, greater efficacy of upper airway surgery, greater CPAP pressure requirement, reduced CPAP efficacy, and reduced CPAP adherence. Associations wlil also be performed using other predicted and actual site of collapse information.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Drug-induced sleep endoscopy
- Keywords
- obstructive sleep apnea, drug-induced sleep endoscopy, polysomnography
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-induced sleep endoscopyProcedure or surgery
Endoscopy during drug-induced sleep
| Study group | Role | What they receive |
|---|---|---|
| Obstructive sleep apnea patients eligible for DISE | Patients with obstructive sleep apnea (AHI>=5) will be included in the study. Subjects should be eligible for drug-induced sleep endoscopy as the next step in their clinical path. Receives: Procedure: Drug-induced sleep endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence or absence of complete concentric collapse of the palate (CCCp) during drug-induced sleep endoscopy
Results of drug-induced sleep endoscopy protocol. This protocol will be performed once in every patient. We will examine whether the odds of CCCP is greater in patients with predicted CCCP vs those with a predicted absence of CCCP.
Measured: 1 procedure (outpatient clinic, up to 40 minutes of recording during drug-induced sleep)
Secondary outcomes (3)
The presence or absence of complete tongue base collapse during drug-induced sleep endoscopy
Results of drug-induced sleep endoscopy protocol. This protocol will be performed once in every patient. We will examine whether the odds of tongue base collapse is greater in patients with predicted presence vs absence of tongue base collapse.
Measured: 1 procedure (outpatient clinic, up to 40 minutes of recording during drug-induced sleep)
The presence or absence of complete lateral wall collapse during drug-induced sleep endoscopy
Results of drug-induced sleep endoscopy protocol. This protocol will be performed once in every patient. We will examine whether the odds of lateral wall collapse is greater in patients with predicted presence vs absence of lateral wall collapse.
Measured: 1 procedure (outpatient clinic, up to 40 minutes of recording during drug-induced sleep)
The presence or absence of complete epiglottic collapse during drug-induced sleep
Results of drug-induced sleep endoscopy protocol. This protocol will be performed once in every patient. We will examine whether the odds of lateral wall collapse is greater in patients with predicted presence vs absence of epiglottic collapse.
Measured: 1 procedure (outpatient clinic, up to 40 minutes of recording during drug-induced sleep)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start1 Feb 2022
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen
- Responsible party
- Sponsor
- Investigators
- Olivier M Vanderveken, MD, PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267808
- Sponsor's protocol ID
- 2021 - 1777
- Status last verified
- Feb 2025
- First submitted
- 8 Feb 2022
- Last updated
- 13 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If IPD will be shared, this will be done anonymously, removing any patient and study identifiers. To further enhance anonymity, data will be shuffled making it impossible to identify patients.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Drug-Induced Sleep Endoscopy Outcome From Baseline Diagnostic Data Including Polysomnography
- ClinicalTrials.gov ID
- NCT05267808
- Acronym / sponsor ID
- 2021 - 1777
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, drug-induced sleep endoscopy, polysomnography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 4 Mar 2022 (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.
The study is designed to develop models to predict site of collapse information using routine polysomnography. In an observational study, the investigators will study 1000 patients with obstructive sleep apnea (OSA) who have had a recent polysomnographic study and will undergo drug-induced sleep endoscopy (DISE) as part of their standard clinical care. Flow shape information from the polysomnographic study will be associated with the DISE results, and a set of prediction models will be developed and validated to detect the site, pattern and degree of upper airway collapse as seen during DISE.
Detailed description
The site, pattern and degree of upper airway collapse is associated with the outcome of different OSA therapies. In current clinical practice, this information is assessed during DISE, in which the upper airway is evaluated during a light sedation, mimicking natural sleep. Information on the site of collapse is not currently available from routine clinical sleep studies.
Recent research has shown that the site of upper airway collapse seen during endoscopy can be recognized from the distinct airflow shape patterns. For example, greater "negative effort dependence" (NED) or inspiratory scooping is associated with non-tongue-base sites of collapse. In preliminary analysis using >150 patients, the investigators recently developed a logistic regression model predicting complete concentric collapse at the level of the palate (CCCp). The model included 6 meaningful airflow features (scoopiness NED, inspiratory skewness, peak flow in early inspiration, inspiratory volume in the first 3rd of inspiration, inspiratory rise time, peak volume). Each feature is calculated as the mean value during identified hypopneas. Other sites of collapse were also assessed using the same six features in separate models (lateral walls, tongue-base, epiglottis).
The study will proceed in two phases of development. In the first phase, the investigators will prospectively validate the preliminary model for predictive CCCP in 300 patients (primary outcome test for phase I). Odds for true CCCP in the predicted CCCP subgroup will be compared against the odds for CCCP in the predicted non-CCCP subgroup (Fisher exact test). Secondary analyses will validate the other three model (lateral walls, tongue-base, epiglottis).
Prior to the second phase, the investigators will develop a refined model to predict CCCP using all available pooled data (N>450). The investigators will seek to include new parameters or incorporate additional interactions between predictors, where appropriate, Refined models for other sites will also be developed. Sensitivity analyses will examine different patterns of collapse (e.g. anterior-posterior), different severities (partial vs complete), how to optimally account for multi-site obstruction, and whether predicted sites are correlated.
In the second phase, the investigators will prospectively apply the refined model to N=700 patients, following the same analytic approach as for phase 1.
Interim analysis will be performed but the study will not be terminated for early success).
Patients will undergo therapies per clinical indication and will be documented; In the entire dataset, the investigators will explore whether the presence of CCCP (per model prediction, and per DISE results) is associated with reduced efficacy of oral appliances, hypoglossal nerve stimulation, positional therapy, greater efficacy of upper airway surgery, greater CPAP pressure requirement, reduced CPAP efficacy, and reduced CPAP adherence. Associations wlil also be performed using other predicted and actual site of collapse information.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obstructive sleep apnea patients eligible for DISE | – | Procedure: Drug-induced sleep endoscopyPatients with obstructive sleep apnea (AHI>=5) will be included in the study. Subjects should be eligible for drug-induced sleep endoscopy as the next step in their clinical path. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosed obstructive sleep apnea, who are eligible for drug-induced sleep endoscopy (DISE) as the next step in their clinical path.
Key inclusion criteria (4 listed)
- 18 years or older.
- Diagnosis with OSA (AHI ≥ 5).
- Eligible for drug-induced sleep endoscopy as the next step in the clinical path for OSA.
- Capable of giving informed consent.
Key exclusion criteria (8 listed)
- Diagnostic polysomnography data not available at the Antwerp University Hospital.
- Factors indicative of unstable clinical status or would preclude DISE investigation:
- Medication use related to sleeping disorders.
- Central Sleep Apnea Syndrome.
- Medical history of known causes of tiredness by day or severe sleep disruption (insomnia, PLMS, Narcolepsy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug-induced sleep endoscopyEndoscopy during drug-induced sleep | Procedure or surgery | Obstructive sleep apnea patients eligible for DISE |
Primary outcome
The presence or absence of complete concentric collapse of the palate (CCCp) during drug-induced sleep endoscopy
Time frame: 1 procedure (outpatient clinic, up to 40 minutes of recording during drug-induced sleep)
Results of drug-induced sleep endoscopy protocol. This protocol will be performed once in every patient. We will examine whether the odds of CCCP is greater in patients with predicted CCCP vs those with a predicted absence of CCCP.
3 secondary outcomes
The presence or absence of complete tongue base collapse during drug-induced sleep endoscopy
Time frame: 1 procedure (outpatient clinic, up to 40 minutes of recording during drug-induced sleep)
The presence or absence of complete lateral wall collapse during drug-induced sleep endoscopy
Time frame: 1 procedure (outpatient clinic, up to 40 minutes of recording during drug-induced sleep)
The presence or absence of complete epiglottic collapse during drug-induced sleep
Time frame: 1 procedure (outpatient clinic, up to 40 minutes of recording during drug-induced sleep)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: Undecided. If IPD will be shared, this will be done anonymously, removing any patient and study identifiers. To further enhance anonymity, data will be shuffled making it impossible to identify patients.
Related trials for Obstructive Sleep Apnea
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)
Enrolling by invitation
Myofunctional Therapy for Obstructive Sleep Apnea
Obstructive Sleep Apnea
Active, not recruiting
The Impact of Technology in Obstructive Sleep Apnea Myofunctional Therapy
Obstructive Sleep Apnea (OSA), Snoring
Recruiting
A Study of the Sleepnet Elara APAP Device
Sleep Apnea - Obstructive
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.
Olivier M Vanderveken, MD, PhD principal investigator
University Hospital, Antwerp
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 8 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: looking for participants now, as of the sponsor's last update on 13 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Op de Beeck, PhD (0032 3 821 3385, sara.opdebeeck@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The presence or absence of complete concentric collapse of the palate (CCCp) during drug-induced sleep endoscopy (time frame: 1 procedure (outpatient clinic, up to 40 minutes of recording during drug-induced sleep)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2025; AzTrials last refreshed its copy on 30 Oct 2026.