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

NCT04729478 | Unknown

• 1 other identifier: B3002021000006
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Flow shape analysis

  Immediately, during the procedure

• Acoustic analysis

  Immediately, during the procedure

Other Outcomes (9)

• Apnea-hypopnea index (AHI)

  Immediately, during polysomnography

• Oxygen desaturation index (ODI)

  Immediately, during polysomnography

• Oxygen saturation (SaO2)

  Immediately, during polysomnography

Study Arms (2)

Natural sleep

OTHER

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

Drug-induced sleep

OTHER

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

Interventions

Drug-induced sleep endoscopy DEVICE

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).

Also known as: DISE

Drug-induced sleep

Natural sleep endoscopy DEVICE

Endoscopy during natural sleep.

Also known as: NSE

Natural sleep

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ethisch.comite@uza.be: lead

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

RECRUITING

Related Publications (1)

• 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.

  PMID: 34950101 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Dyssomnias; Sleep Disorders, Intrinsic; Sleep Wake Disorders; Nervous System Diseases

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Neurologic Manifestations

Study Officials

• Olivier Vanderveken, MD, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karlien Van den Bossche, MD

CONTACT

38212173; karlien.vandenbossche@uza.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: NSE and DISE will be performed by two separate researchers, blinding the ENT surgeon who performs the NSE or DISE for the outcome of the other procedure. This is a blinded study and the researchers will have no knowledge of the patient's characteristics / demographic variables and their history.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Olivier Vanderveken, Professor and Chair Otorhinolaryngology

Model Details: Blinded, prospective, single-center, comparative cohort study.

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 28, 2021
• Study Start: March 30, 2021
• Primary Completion: August 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 26, 2021

Record last verified: 2021-07

Locations

BE (1)