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

CompletedOBSERVATIONAL
Enrollment

13

Participants

Timeline

Start Date

January 15, 2020

Primary Completion Date

October 27, 2020

Study Completion Date

December 1, 2020

Conditions
Obstructive Sleep Apnea
Interventions
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.

DIAGNOSTIC_TEST

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.

Trial Locations (1)

2650

Antwerp University Hospital, Edegem

All Listed Sponsors
lead

University Hospital, Antwerp

OTHER

NCT04232410 - Measurement of Critical Closing Pressure (Pcrit) During Drug-Induced Sleep Endoscopy (DISE) | Biotech Hunter | Biotech Hunter