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

NCT ID: NCT04729478

Last Updated: 2021-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-30
• Study Completion Date: 2022-12-31

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: OTHER

Natural sleep endoscopy

Intervention Type: DEVICE

Endoscopy during natural sleep.

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.

Group Type: OTHER

Drug-induced sleep endoscopy

Intervention Type: 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).

Interventions

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).

Intervention Type: DEVICE

Natural sleep endoscopy

Endoscopy during natural sleep.

Intervention Type: DEVICE

Other Intervention Names

DISE; NSE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ethisch.comite@uza.be

OTHER

Sponsor Role: lead

Responsible Party

ethisch.comite@uza.be

Olivier Vanderveken, Professor and Chair Otorhinolaryngology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Olivier Vanderveken, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

Antwerp University Hospital

Edegem, Antwerp, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Karlien Van den Bossche, MD

Role: CONTACT

karlien.vandenbossche@uza.be

38212173 ext. +32

Facility Contacts

Karlien Van den Bossche, MD

Role: primary

karlien.vandenbossche@uza.be

38212173 ext. +32

References

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.

Reference Type: DERIVED

PMID: 34950101 (View on PubMed)

Other Identifiers

B3002021000006

Identifier Type: -

Identifier Source: org_study_id