Pathophysiological Endotyping Using Baseline Polysomnography Data
Recruiting now
Conditions studied: Obstructive Sleep Apnea
In brief
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.
Key facts
- Study ID
- NCT05267808
- Run by
- University Hospital, Antwerp
- People needed
- 1000
- Starts
- 2022-02-01
- Expected to finish
- 2026-01-01
- Last updated by the study team
- 2025-02-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Antwerp University Hospital — Edegem, Belgium (enrolling)
Full record on ClinicalTrials.gov
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