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

NCT ID: NCT04232410

Last Updated: 2021-08-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 13 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2020-12-01

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

OSA Pcrit-DISE

Patients diagnosed with OSA and eligible for non-CPAP treatments

Drug induced sleep endoscopy

Intervention Type: 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.

Measurement of critical closing pressure of the uppper airway

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

DISE; Pcrit measurement

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

ethisch.comite@uza.be

Prof. Dr. Olivier Vanderveken

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olivier Vanderveken, MD, PhD

Role: STUDY_CHAIR

Head of ENT department, UZA

Locations

Antwerp University Hospital

Edegem, Antwerp, Belgium

Countries

Belgium

References

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.

Reference Type: BACKGROUND

PMID: 28364460 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8874271 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37259138 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35112928 (View on PubMed)

Other Identifiers

BE300201940940

Identifier Type: -

Identifier Source: org_study_id