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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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 |
| 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 |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karlien Van den Bossche, MD | Contact | 38212173 | +32 | karlien.vandenbossche@uza.be |
| Name | Affiliation | Role |
|---|---|---|
| Olivier Vanderveken, MD, PhD | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp University Hospital | Recruiting | Edegem | Antwerp | 2650 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34950101 | Derived | 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. |
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Blinded, prospective, single-center, comparative cohort study.
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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.
|
| Natural sleep endoscopy | Device | Endoscopy during natural sleep. |
|
|
Acoustic analyses measured during both natural and drug-induced sleep endoscopy |
| Immediately, during the procedure |
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 |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020920 | Dyssomnias |
| D020919 | Sleep Disorders, Intrinsic |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
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