Clinical trial NCT04729478: Comparison Between Natural Sleep Endoscopy and Drug-induced Sleep Endoscopy in Patients With Obstructive Sleep Apnea
Official title: Comparison Between Natural Sleep Endoscopy and Drug-induced Sleep Endoscopy in Patients With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Keywords: Sleep endoscopy
Sedation
Airflow analysis
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Blinded, prospective, single-center, comparative cohort study.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Endoscopic Classification System
timeFrame: Immediately, during the procedure
Secondary outcomes:
measure: Flow shape analysis
timeFrame: Immediately, during the procedure
measure: Acoustic analysis
timeFrame: Immediately, during the procedure
Other outcomes:
measure: Apnea-hypopnea index (AHI)
timeFrame: Immediately, during polysomnography
measure: Oxygen desaturation index (ODI)
timeFrame: Immediately, during polysomnography
measure: Oxygen saturation (SaO2)
timeFrame: Immediately, during polysomnography
measure: Apnea index
timeFrame: Immediately, during polysomnography
measure: Arousal index
timeFrame: Immediately, during polysomnography
measure: Arousal threshold
timeFrame: Immediately, during polysomnography
measure: Daytime sleepiness measured with the Epworth Sleepiness Scale (ESS)
timeFrame: Immediately, before the procedure
measure: Checklist Individual Strength questionnaire (CIS20R) for fatigue
timeFrame: Immediately, before the procedure
measure: Snoring intensity measured with a Visual Analogue Scale (VAS)
timeFrame: Immediately, before the procedure
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Olivier Vanderveken, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van den Bossche K, Van de Perck E, Wellman A, Kazemeini E, Willemen M, Verbraecken J, Vanderveken OM, Vena D, Op de Beeck S. Comparison of Drug-Induced Sleep Endoscopy and Natural Sleep Endoscopy in the Assessment of Upper Airway Pathophysiology During Sleep: Protocol and Study Design. Front Neurol. 2021 Dec 7;12:768973. doi: 10.3389/fneur.2021.768973. eCollection 2021.