Status:
COMPLETED
Correlation Between Upper Airway Endoscopy and Physiological Traits of Obstructive Sleep Apnea
Lead Sponsor:
University Hospital, Antwerp
Collaborating Sponsors:
Brigham and Women's Hospital
Harvard Medical School (HMS and HSDM)
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Brief Summary
OBJECTIVES To train and test a mathematical model to predict complete concentric collapse at the level of the palate (CCCp, primary) and other sites of upper airway collapse (secondary) during drug-i...
Eligibility Criteria
Inclusion
- 18 years or older.
- Diagnosis with symptomatic moderate to severe OSA (AHI ≥ 15/h).
- Underwent DISE at UZA as part of the clinical pathway for non-continuous positive airway pressure (CPAP) therapies
- Underwent a baseline diagnostic PSG at UZA max 2 years before DISE
Exclusion
- Medication use related to sleeping disorders
- Central Sleep Apnea Syndrome.
- Medical history of known causes of tiredness by day or severe sleep disruption (insomnia, periodic leg movements, narcolepsy).
- Seizure disorder.
- 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
- \<4 h of data recording during the baseline PSG night
Key Trial Info
Start Date :
February 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2021
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT04753684
Start Date
February 15 2021
End Date
October 31 2021
Last Update
November 30 2021
Active Locations (1)
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1
UZA
Edegem, Antwerp, Belgium, 2650