Comparison Between Natural Sleep Endoscopy and Drug-induced Sleep Endoscopy in Patients With Obstructive Sleep Apnea
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hypnotics and Sedatives
- Apnea
- Central Nervous System Depressants
- Dyssomnia
- General Anesthetics
- Sleep Wake Disorders
- Midazolam
- Nervous System Diseases
- Sleep Apnea Syndromes
- Sleep Disorders, Intrinsic
- Sleep Apnea
- Physiological Effects of Drugs
- Propofol
- Respiration Disorder
- Sleep Apnea - Obstructive
- Respiratory Tract Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Single Group AssignmentIntervention Model Description: Blinded, prospective, single-center, comparative cohort study.Masking: Single (Outcomes Assessor)Masking Description: NSE and DISE will be performed by two separate researchers, blinding the ENT surgeon who performs the NSE or DISE for the outcome of the other procedure. This is a blinded study and the researchers will have no knowledge of the patient's characteristics / demographic variables and their history.Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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, followed by a DISE at the operating theatre the morning after. Both the NSE and DISE set-up will include gold-standard flo...
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, followed by a DISE at the operating theatre the morning after. Both the NSE and DISE set-up will include gold-standard flow measurements, acoustic analysis and esophageal pressure measurements.
Tracking Information
- NCT #
- NCT04729478
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Olivier Vanderveken, MD, PhD University Hospital, Antwerp
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