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This study intends to test the feasibility of measurement of the critical closing pressure (Pcrit) during drug-induced sleep endoscopy (DISE) for use in future studies, which are aimed at finding an alternative method for patient selection and response prediction before implementation of non-CPAP therapies.Twenty patients diagnosed with OSA and eligible for non-CPAP treatments are going to be included into this study and undergo these measurements. Drug-induced sleep endoscopy (DISE) is part of the standard clinical care for OSA patients that are eligible for non-CPAP therapies. We aim to expand this procedure with measurement of Pcrit, oesophageal pressure, airflow, EEG, EOG, respiratory effort, SpO2 and chin EMG during this study.
Patients from the ENT department will be recruited and informed about the study. After obtaining informed consent, the patients will undergo DISE according to the normal clinical care.The study will be performed during this clinical DISE, using a standard polysomnographic set-up (Alice 6 LDx, Philips Respironics) expanded with pressure and flow measurements. After measurements and evaluations are done, the most suitable treatment option based on the DISE and PSG findings, as defined in the standard clinical care, will be advised to the patient. The treatment and its further choice are not part of the current study protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSA Pcrit-DISE | Patients diagnosed with OSA and eligible for non-CPAP treatments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug induced sleep endoscopy | Diagnostic Test | DISE is performed in a semi-dark, silent operating theatre, starting with the patient in supine position. To first induce sleep, an IV bolus of midazolam (1.5 mg) is administered. Then, a flexible fiberoptic nasopharyngoscope (Olympus END-GP, 3.7 mm diameter, Olympus Europe GmbH, Hamburg, Germany) is inserted through one of the nostrils. Either at the start of the examination or while holding the scope at the level of the palate, propofol (2.0-3.0 µg/ml) will be administered via a target-controlled infusion (TCI) pump. Sleep occurrence is confirmed using the additional EEG measurement. |
| Measure | Description | Time Frame |
|---|---|---|
| Critical closing pressure of the upper airway (Pcrit) | The pressure at which the upper airway collpases measured in cm H2O. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Airflow | By using a pneumotachometer attached to a transducer the inspiratory and expiratory airflow (l/s) will be measured. | 1 hour |
| EEG | Using electroencephalogram electrodes C3, C4, O1, F4 to evaluate sleep and wake stages and ground and system reference electrodes (volt) |
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Inclusion Criteria:
Exclusion Criteria:
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Twenty patients diagnosed with OSA and eligible for non-CPAP
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| Name | Affiliation | Role |
|---|---|---|
| Olivier Vanderveken, MD, PhD | Head of ENT department, UZA | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp University Hospital | Edegem | Antwerp | 2650 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28364460 | Background | Azarbarzin A, Sands SA, Taranto-Montemurro L, Oliveira Marques MD, Genta PR, Edwards BA, Butler J, White DP, Wellman A. Estimation of Pharyngeal Collapsibility During Sleep by Peak Inspiratory Airflow. Sleep. 2017 Jan 1;40(1):zsw005. doi: 10.1093/sleep/zsw005. | |
| 8874271 | Background | Gold AR, Schwartz AR. The pharyngeal critical pressure. The whys and hows of using nasal continuous positive airway pressure diagnostically. Chest. 1996 Oct;110(4):1077-88. doi: 10.1378/chest.110.4.1077. No abstract available. |
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The patient data is coded and only the investigators will have access to the data.
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| Measurement of critical closing pressure of the uppper airway | Diagnostic Test | After sleep onset, the CPAP pressure well be increased until no flow limitations are observed. This pressure is called the holding pressure and is used as a base for all the following measurements for that individual OSA patient. After observing sleep stage 2 or 3, the holding pressure is reduced abruptly by 1 cmH2O during expiration for 5 breaths. Then the pressure is set back to the holding pressure for the duration of 1 minute. This procedure is repeated until obstructive sleep apnea is noted. |
|
|
| 1 hour |
| Esophageal pressure | The pressure of the esophagus measured in cmH2O using an esophageal ballooon catheter. | 1 hour |
| SpO2 | using a pulse oximetry device, to non-invasively measure arterial oxygen saturation level (%). | 1 hour |
| EMG | Using electromyogram electrodes to evaluate muscular activity (volt) | 1 hour |
| EOG | electrooculogram electrodes to evaluate rapid eye movements (volt) | 1 hour |
| 37259138 | Derived | Van de Perck E, Kazemeini E, Van den Bossche K, Willemen M, Verbraecken J, Vanderveken OM, Op de Beeck S. The effect of CPAP on the upper airway and ventilatory flow in patients with obstructive sleep apnea. Respir Res. 2023 May 31;24(1):143. doi: 10.1186/s12931-023-02452-z. |
| 35112928 | Derived | Kazemeini E, Van de Perck E, Dieltjens M, Willemen M, Verbraecken J, Sands SA, Vanderveken OM, Op de Beeck S. Critical closing pressure of the pharyngeal airway during routine drug-induced sleep endoscopy: feasibility and protocol. J Appl Physiol (1985). 2022 Apr 1;132(4):925-937. doi: 10.1152/japplphysiol.00624.2021. Epub 2022 Feb 3. |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |