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

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).

Study Overview

• Status: Recruiting
• Conditions: Nervous System Diseases; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Sleep Disorders, Intrinsic; Sleep Wake Disorders; Sleep Apnea; Propofol; Respiratory Tract Disease; Physiological Effects of Drugs; Central Nervous System Depressants; Respiration Disorder; Midazolam; Dyssomnia; Hypnotics and Sedatives; General Anesthetics
• Intervention / Treatment: Device: Natural sleep endoscopy; Device: Drug-induced sleep endoscopy

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karlien Van den Bossche, MD; Phone Number: +32 38212173; Email: karlien.vandenbossche@uza.be

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Recruiting
      • Antwerp University Hospital
      • Principal Investigator: Olivier Vanderveken, MD, PhD
      • Contact: Karlien Van den Bossche, MD; Phone Number: +32 38212173; Email: karlien.vandenbossche@uza.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Natural sleep; 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; Endoscopy during natural sleep.; Other Names: NSE
Other: Drug-induced sleep; 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; 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).; Other Names: DISE

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea-hypopnea index (AHI)	The AHI is an index of sleep apnea severity that encompasses the frequency of apneas (cessations in breathing) and hypopneas (reductions in airflow).	Immediately, during polysomnography
Oxygen desaturation index (ODI)	The ODI represents the average number of desaturation episodes (≥3%) per hour sleep.	Immediately, during polysomnography
Oxygen saturation (SaO2)	Minimal and mean SaO2 (%)	Immediately, during polysomnography
Apnea index	The apnea index is an index of sleep apnea severity that encompasses the frequency of apneas.	Immediately, during polysomnography
Arousal index	The arousal index is an indirect indicator of sleep apnea severity that encompasses the number of arousals related to total sleep time.	Immediately, during polysomnography
Arousal threshold	The occurrence of arousal from sleep with a rise in ventilatory drive.	Immediately, during polysomnography
Daytime sleepiness measured with the Epworth Sleepiness Scale (ESS)	The probability of falling asleep in various settings and situations in daily life will be assessed. This questionnaire consists of eight questions which can be scored on a four-point Likert-type scale. The lowest score (zero) suggests that the described incident is absent and the highest score (three) suggests the presence of this event. The summation of the eight items can range from 0 to 24.	Immediately, before the procedure
Checklist Individual Strength questionnaire (CIS20R) for fatigue	The checklist individual strength (CIS20R) is a 20-item questionnaire to assess the degree of fatigue. The patient selects the most appropriate score on each statement ranging from 1 (yes, this is true) to 7 (no, this is not true). The total score, calculated as the sum of the questions, may yield to a maximum of 140. The CIS20R measures four dimensions of fatigue: fatigue severity (8 items), concentration problems (5 items), reduced motivation (4 items) and activity (3 items).	Immediately, before the procedure
Snoring intensity measured with a Visual Analogue Scale (VAS)	The subjective degree of snoring during sleep will be evaluated by the partner of a subject by using a VAS scoring system ranging from 0 (no snoring) to 10 (extreme snoring causing the bed partner to sleep separately). Heavy snoring is determined as a snoring index ≥7.	Immediately, before the procedure

Collaborators and Investigators

• Sponsor: ethisch.comite@uza.be
• Investigators: Principal Investigator: Olivier Vanderveken, MD, PhD, University Hospital, Antwerp

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2021
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Actual): July 26, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Sedation; Sleep endoscopy; Airflow analysis
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurologic Manifestations; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Disease; Sleep Wake Disorders; Apnea; Dyssomnias; Nervous System Diseases; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic
• Other Study ID Numbers: B3002021000006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No