Actively Recruiting

Age: 18Years +
All Genders
ID05267808

Prediction of Drug-Induced Sleep Endoscopy Outcome From Baseline Diagnostic Data Including Polysomnography

Led by University Hospital, Antwerp · Updated on 2025-02-13

1000

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Antwerp

Lead Sponsor

U

Universiteit Antwerpen

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating how to predict the site, pattern, and degree of upper airway collapse in patients with obstructive sleep apnea (OSA) using routine polysomnography data. The study focuses on developing and validating models that link airflow shape features from sleep studies with observations made during drug-induced sleep endoscopy (DISE), which is part of standard care. Understanding these collapse patterns is important because they affect the outcomes of different OSA therapies. The study will enroll 1000 patients with OSA who recently had polysomnography and will undergo DISE. In the first phase, a preliminary model predicting complete concentric collapse of the palate (CCCp) will be validated in 300 patients. Later, refined models using pooled data will be developed and tested in 700 patients. Throughout the study, patients will receive therapies as clinically indicated, and researchers will explore how the predicted and actual collapse sites relate to treatment effectiveness and adherence. Participants will undergo one DISE procedure lasting up to 40 minutes during drug-induced sleep. Researchers will collect and analyze polysomnography data alongside DISE results to develop prediction models for different collapse sites. The primary outcome is the presence or absence of CCCp during DISE, with secondary measures including collapse of the tongue base, lateral walls, and epiglottis. The study will monitor associations between collapse patterns and therapy outcomes. Participation involves data collection from existing clinical procedures and no experimental treatments are administered.

CONDITIONS

Brief Title

Pathophysiological Endotyping Using Baseline Polysomnography Data

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Diagnosis of obstructive sleep apnea with apnea-hypopnea index (AHI) of 5 or higher
  • Eligible for drug-induced sleep endoscopy as the next clinical step
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Diagnostic polysomnography data not available at Antwerp University Hospital
  • Unstable clinical status preventing DISE investigation
  • Use of medication related to sleep disorders
  • Central Sleep Apnea Syndrome
  • Medical history of daytime tiredness causes or severe sleep disruption (insomnia, PLMS, narcolepsy)
  • Seizure disorders
  • Known intellectual disability, memory disorders, or current psychiatric conditions (psychotic illness, major depression, acute anxiety attacks)
  • Pregnancy or planning to become pregnant

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single procedure lasting up to 40 minutes

Participants undergo drug-induced sleep endoscopy to assess the site and degree of upper airway collapse during light sedation mimicking natural sleep.

1 visit (outpatient clinic)

Long-term Monitoring

Duration - Ongoing during clinical care until study completion

Participants' clinical therapies and outcomes are documented and observed to explore associations with airway collapse patterns identified from diagnostic procedures.

Visits as per routine clinical care; no additional study visits required

Trial Site Locations

Total: 1 location

1

Antwerp University Hospital

Edegem, Belgium, 2650

Actively Recruiting

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Research Team

S

Sara Op de Beeck, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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