An interventional study of Drug-induced sleep endoscopy and Natural sleep endoscopy in Sleep Apnea, Obstructive, Sleep Apnea and Sleep Apnea Syndromes, sponsored by ethisch.comite@uza.be. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-26.
Sponsored by ethisch.comite@uza.be · Not applicable, Interventional, and Diagnostic
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).
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →ethisch.comite@uza.be is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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 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).
Also known as: DISE
Endoscopy during natural sleep.
Also known as: NSE
Endoscopic Classification System
Comparison of the frequencies of the site, gradation and pattern of upper airway collapse between natural and drug-induced sleep endoscopy.
Time frame: Immediately, during the procedure
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.
Time frame: Immediately, during the procedure
Acoustic analysis
Acoustic analyses measured during both natural and drug-induced sleep endoscopy
Time frame: Immediately, during the procedure
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).
Time frame: Immediately, during polysomnography
Oxygen desaturation index (ODI)
The ODI represents the average number of desaturation episodes (≥3%) per hour sleep.
Time frame: Immediately, during polysomnography
Oxygen saturation (SaO2)
Minimal and mean SaO2 (%)
Time frame: Immediately, during polysomnography
Apnea index
The apnea index is an index of sleep apnea severity that encompasses the frequency of apneas.
Time frame: 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.
Time frame: Immediately, during polysomnography
Arousal threshold
The occurrence of arousal from sleep with a rise in ventilatory drive.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Immediately, before the procedure
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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ethisch.comite@uza.be