Status:
UNKNOWN
Comparison Between Natural Sleep Endoscopy and Drug-induced Sleep Endoscopy in Patients With Obstructive Sleep Apnea
Lead Sponsor:
ethisch.comite@uza.be
Conditions:
Sleep Apnea, Obstructive
Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Drug-induced sleep endoscopy (DISE) is the most used technique for identifying the obstruction site associated with obstructive sleep apnea (OSA). This is due to the fact that it allows many patients ...
Detailed Description
Patients with moderate to severe OSA requiring DISE will be recruited for this prospective study at the outpatient clinic. Patients will undergo a NSE at the sleep lab at night, and a DISE at the oper...
Eligibility Criteria
Inclusion
- Diagnosis of OSA with a baseline AHI ≥ 15 per hour based on full polysomnography
- Body mass index (BMI) ≤ 35 kg/m²
- Capability of giving informed consent and willingness to undergo NSE
Exclusion
- Central sleep apnea (defined as CAHI ≥ 30% of total AHI)
- Inability to sleep in a supine position due to a medical condition
- Inability of the patient to understand and/or comply to the study procedures
- Neuromuscular disorders or craniofacial anomalies affecting the UA
- Sedative medication use (opioids and muscle relaxants)
- Active psychiatric disorders (psychotic illness, major depression, anxiety attacks, excessive alcohol or drug use)
- Severe or decompensated cardiac or respiratory diseases
- Medical history of known causes of tiredness by day or severe sleep disruption (insomnia, PLMS, narcolepsy)
- Contra-indications for DISE: i.e. fitness for general anesthesia (ASA\>3), allergy to sedative agent(s) and an expected extremely difficult airway
- Pregnancy or willing to become pregnant
Key Trial Info
Start Date :
March 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04729478
Start Date
March 30 2021
End Date
December 31 2022
Last Update
July 26 2021
Active Locations (1)
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1
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650