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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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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

Intervention / Treatment
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* Device: Drug-induced sleep endoscopy
* Device: Natural sleep endoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Blinded, prospective, single-center, comparative cohort study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Natural sleep<br>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. | Device: Natural sleep endoscopy<br>* Endoscopy during natural sleep.<br>* Other names: NSE;|
| Other: Drug-induced sleep<br>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. | Device: Drug-induced sleep endoscopy<br>* 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).<br>* Other names: DISE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic Classification System | Comparison of the frequencies of the site, gradation and pattern of upper airway collapse between natural and drug-induced sleep endoscopy. | Immediately, during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow shape analysis | 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. | Immediately, during the procedure | 
| Acoustic analysis | Acoustic analyses measured during both natural and drug-induced sleep endoscopy | Immediately, during the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep endoscopy, Sedation, Airflow analysis