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

NCT04232410 | Completed DMC

• 1 other identifier: BE300201940940
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Critical closing pressure of the upper airway (Pcrit)

  The pressure at which the upper airway collpases measured in cm H2O.

  1 hour

Secondary Outcomes (6)

• Airflow

  1 hour

• EEG

  1 hour

• Esophageal pressure

  1 hour

• SpO2

  1 hour

• EMG

  1 hour

Study Arms (1)

OSA Pcrit-DISE

Patients diagnosed with OSA and eligible for non-CPAP treatments

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

Interventions

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.

Also known as: DISE

OSA Pcrit-DISE

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.

Also known as: Pcrit measurement

OSA Pcrit-DISE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Twenty patients diagnosed with OSA and eligible for non-CPAP

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

Related Publications (4)

• 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.

  PMID: 28364460 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.

  PMID: 8874271 BACKGROUND

• 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.

  PMID: 37259138 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.

  PMID: 35112928 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Olivier Vanderveken, MD, PhD

  Head of ENT department, UZA

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Olivier Vanderveken

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: January 15, 2020
• Primary Completion: October 27, 2020
• Study Completion: December 1, 2020
• Last Updated: August 5, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)