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

Not Applicable

• Conditions: Dyssomnia; Physiological Effects of Drugs; Sleep Apnea, Obstructive; Respiratory Tract Disease; Hypnotics and Sedatives; Central Nervous System Depressants; Respiration Disorder; Sleep Wake Disorders; Midazolam; Sleep Apnea
• Interventions: Device: Natural sleep endoscopy; Device: Drug-induced sleep endoscopy

• Registration Number: NCT04729478
• Lead Sponsor: ethisch.comite@uza.be

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 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.

Study Timeline

• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-01-26
• Study First Posted: 2021-01-28
• Study Start: 2021-03-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-26
• Primary Completion: 2022-08-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Natural sleep	Natural sleep endoscopy	Natural sleep endoscopy (NSE) OSA patients will be endoscopically evaluated during natural sleep. During NSE additional physiological measurements (flow shape analysis, acoustic analysis of snoring sounds and esophageal pressure measurements) will be carried out.
Drug-induced sleep	Drug-induced sleep endoscopy	Drug-induced sleep endoscopy (DISE) OSA patients will be endoscopically evaluated during drug-induced sleep. During DISE additional physiological measurements (flow shape analysis, acoustic analysis of snoring sounds and esophageal pressure measurements) will be carried out.

Primary Outcome Measures

Name	Time	Method
Endoscopic Classification System	Immediately, during the procedure	Comparison of the frequencies of the site, gradation and pattern of upper airway collapse between natural and drug-induced sleep endoscopy.

Secondary Outcome Measures

Name	Time	Method
Acoustic analysis	Immediately, during the procedure	Acoustic analyses measured during both natural and drug-induced sleep endoscopy
Flow shape analysis	Immediately, during the procedure	Several parameters extracted from the flow signal, including negative effort dependence (NED), peak inspiratory flow, etc. measured during both natural and drug-induced sleep endoscopy.

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Edegem, Antwerp, Belgium