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

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Status: Unknown

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

Treatments: Device: Drug-induced sleep endoscopy; Device: Natural sleep endoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT04729478

B3002021000006

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Natural sleep

Other group

Description:

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.

Treatment:

Device: Natural sleep endoscopy

Drug-induced sleep

Other group

Description:

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.

Treatment:

Device: Drug-induced sleep endoscopy