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

Obstructive Sleep Apnea Clinical Trial

— Pcrit-DISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04232410
• Other study ID #: BE300201940940
• Status: Completed
• Start date: January 15, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: July 2021
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 1, 2020
• Est. primary completion date: October 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Diagnostic Test:
• Drug induced sleep endoscopy
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.
• Measurement of critical closing pressure of the uppper airway
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.

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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). doi: 10.1093/sleep/zsw005. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Critical closing pressure of the upper airway (Pcrit)	The pressure at which the upper airway collpases measured in cm H2O.	1 hour
Secondary	Airflow	By using a pneumotachometer attached to a transducer the inspiratory and expiratory airflow (l/s) will be measured.	1 hour
Secondary	EEG	Using electroencephalogram electrodes C3, C4, O1, F4 to evaluate sleep and wake stages and ground and system reference electrodes (volt)	1 hour
Secondary	Esophageal pressure	The pressure of the esophagus measured in cmH2O using an esophageal ballooon catheter.	1 hour
Secondary	SpO2	using a pulse oximetry device, to non-invasively measure arterial oxygen saturation level (%).	1 hour
Secondary	EMG	Using electromyogram electrodes to evaluate muscular activity (volt)	1 hour
Secondary	EOG	electrooculogram electrodes to evaluate rapid eye movements (volt)	1 hour