Status:
RECRUITING
Pathophysiological Endotyping Using Baseline Polysomnography Data
Lead Sponsor:
University Hospital, Antwerp
Collaborating Sponsors:
Universiteit Antwerpen
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
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 sl...
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 up...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05267808
Start Date
February 1 2022
End Date
January 1 2026
Last Update
February 13 2025
Active Locations (1)
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1
Antwerp University Hospital
Edegem, Belgium, 2650