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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UZA

Edegem, Antwerp, Belgium, 2650