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

ethisch.comite@uza.be40 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Sleep Apnea, Obstructive Sleep Apnea

Interventions

Drug-induced sleep endoscopyDEVICE

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).

Natural sleep endoscopyDEVICE

Endoscopy during natural sleep.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Endoscopic Classification System

Comparison of the frequencies of the site, gradation and pattern of upper airway collapse between natural and drug-induced sleep endoscopy.

Time frame: Immediately, during the procedure

Secondary Outcomes

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.

Time frame: Immediately, during the procedure

Acoustic analysis

Acoustic analyses measured during both natural and drug-induced sleep endoscopy

Time frame: Immediately, during the procedure

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts