NCT04729478

Comparison Between Natural Sleep Endoscopy and Drug-induced Sleep Endoscopy in Patients With Obstructive Sleep Apnea

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: [e-mail] · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 to be examined in a daytime setting. This procedure uses sedative drugs to mimic natural sleep. However, associations with the site of upper airway (UA) collapse during natural sleep remain unclear. The aim of this explorative study is to identify UA collapse in patients with OSA using endoscopic techniques as well as flow shape characteristics and sound analyses during natural and drug-induced sleep. Furthermore, we want to optimize the measurement set-up of natural sleep endoscopy (NSE).

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 operating theatre within three months. Both the NSE and DISE set-up will include gold-standard flow measurements, acoustic analysis and esophageal pressure measurements.

Conditions

• Sleep Apnea, Obstructive
• Sleep Apnea
• Sleep Apnea Syndromes
• Apnea
• Respiration Disorder
• Respiratory Tract Disease
• Dyssomnia
• Sleep Disorders, Intrinsic
• Sleep Wake Disorders
• Nervous System Diseases
• Hypnotics and Sedatives
• Central Nervous System Depressants
• Propofol
• Midazolam
• Physiological Effects of Drugs
• General Anesthetics

Interventions

Type	Name	Description
DEVICE	Drug-induced sleep endoscopy	An intravenous bolus injection of midazolam 1.5 mg will be used to induce sleep. Maintenance of sedated sleep will be obtained by a target-controlled infusion of propofol (2.0-3.0 µg/mL).
DEVICE	Natural sleep endoscopy	Endoscopy during natural sleep.

Timeline

• Start date: 2021-03-30
• Primary completion: 2022-08-31
• Completion: 2022-12-31
• First posted: 2021-01-28
• Last updated: 2021-07-26

Locations

1 site across 1 country: Belgium