Measurement of Critical Closing Pressure (Pcrit) During Drug-Induced Sleep Endoscopy (DISE)

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Diagnostic Test: Drug induced sleep endoscopy; Diagnostic Test: Measurement of critical closing pressure of the uppper airway

• Registration Number: NCT04232410
• Lead Sponsor: University Hospital, Antwerp

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-01-14
• Study Start: 2020-01-15
• Study First Posted: 2020-01-18
• Primary Completion: 2020-10-27
• Study Completion: 2020-12-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-29
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• 18 years or older
• Diagnosis with OSA (AHI ≥15/hour sleep)
• Eligible for DISE as the next step in the clinical path for OSA.
• Capable of giving informed consent

Exclusion Criteria

• Medication use related to sleeping disorders.
• Central sleep apnea syndrome.
• Medical history of known causes of tiredness or severe sleep disruption other than OSA (insomnia, PLMS, Narcolepsy).
• Seizure disorder.
• Known medical history of intellectual disability, memory disorders or current psychiatric disorders (psychotic illness, major depression, or acute anxiety attacks as mentioned by the patient).
• Inability to provide informed consent.
• Simultaneous use of other treatment modalities to treat OSA
• Esophageal ulceration, tumors, diverticulitis, bleeding varices, sinusitis, epistaxis, recent nasopharyngeal surgery
• Pregnancy or willing to become pregnant
• Excessive alcohol or drug use (> 20 alcohol units/week or any use of hard drugs)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OSA Pcrit-DISE	Drug induced sleep endoscopy	Patients diagnosed with OSA and eligible for non-CPAP treatments
OSA Pcrit-DISE	Measurement of critical closing pressure of the uppper airway	Patients diagnosed with OSA and eligible for non-CPAP treatments

Primary Outcome Measures

Name	Time	Method
Critical closing pressure of the upper airway (Pcrit)	1 hour	The pressure at which the upper airway collpases measured in cm H2O.

Secondary Outcome Measures

Name	Time	Method
Esophageal pressure	1 hour	The pressure of the esophagus measured in cmH2O using an esophageal ballooon catheter.
Airflow	1 hour	By using a pneumotachometer attached to a transducer the inspiratory and expiratory airflow (l/s) will be measured.
EEG	1 hour	Using electroencephalogram electrodes C3, C4, O1, F4 to evaluate sleep and wake stages and ground and system reference electrodes (volt)
SpO2	1 hour	using a pulse oximetry device, to non-invasively measure arterial oxygen saturation level (%).
EOG	1 hour	electrooculogram electrodes to evaluate rapid eye movements (volt)
EMG	1 hour	Using electromyogram electrodes to evaluate muscular activity (volt)

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Edegem, Antwerp, Belgium