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

Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04729478
• Other study ID #: B3002021000006
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2021
• Source: University Hospital, Antwerp
• Contact: Karlien Van den Bossche, MD
• Phone: 38212173
• Email: karlien.vandenbossche[@]uza.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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).
• Natural sleep endoscopy
Endoscopy during natural sleep.

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
ethisch.comite@uza.be

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Oxygen desaturation index (ODI)	The ODI represents the average number of desaturation episodes (=3%) per hour sleep.	Immediately, during polysomnography
Other	Oxygen saturation (SaO2)	Minimal and mean SaO2 (%)	Immediately, during polysomnography
Other	Apnea index	The apnea index is an index of sleep apnea severity that encompasses the frequency of apneas.	Immediately, during polysomnography
Other	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
Other	Arousal threshold	The occurrence of arousal from sleep with a rise in ventilatory drive.	Immediately, during polysomnography
Other	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
Other	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
Other	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
Primary	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	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
Secondary	Acoustic analysis	Acoustic analyses measured during both natural and drug-induced sleep endoscopy	Immediately, during the procedure