NCT05267808 Pathophysiological Endotyping Using Baseline Polysomnography Data
| NCT ID | NCT05267808 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Antwerp |
| Condition | Obstructive Sleep Apnea |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2022-02-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2022-02-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
Olivier M Vanderveken, MD, PhD
PRINCIPAL INVESTIGATOR
University Hospital, Antwerp
Frequently Asked Questions
Who can join the NCT05267808 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05267808 currently recruiting?
Yes, NCT05267808 is actively recruiting participants. Contact the research team at sara.opdebeeck@uza.be for enrollment information.
Where is the NCT05267808 trial being conducted?
This trial is being conducted at Edegem, Belgium.
Who is sponsoring the NCT05267808 clinical trial?
NCT05267808 is sponsored by University Hospital, Antwerp. The principal investigator is Olivier M Vanderveken, MD, PhD at University Hospital, Antwerp. The trial plans to enroll 1,000 participants.