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Obstructive Sleep ApneaPcrit-DISENCT04232410

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

An observational study of Obstructive Sleep Apnea, run by University Hospital, Antwerp at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obstructive Sleep Apnea
What is being tested?
Drug induced sleep endoscopy and Measurement of critical closing pressure of the uppper airway
Type of treatment
Injection or infusion
How many people
13 participants
Where
1 siteBelgium
Study dates
15 Jan 2020to 1 Dec 2020
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Twenty patients diagnosed with OSA and eligible for non-CPAP

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 10Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Antwerp University Hospital

    Edegem, Antwerp, 2650

Other trials in Belgium

About this study

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.

Read the 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.

Being tested
Drug induced sleep endoscopy, Measurement of critical closing pressure of the uppper airway
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drug induced sleep endoscopyDiagnostic test

    Also called DISE

    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 airwayDiagnostic test

    Also called Pcrit measurement

    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.

Study groups in NCT04232410
Study groupRoleWhat they receive
OSA Pcrit-DISEPatients diagnosed with OSA and eligible for non-CPAP treatments
Receives: Diagnostic Test: Drug induced sleep endoscopy; Diagnostic Test: Measurement of critical closing pressure of the uppper airway

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Critical closing pressure of the upper airway (Pcrit)

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

    Measured: 1 hour

Secondary outcomes (6)

  1. Airflow

    By using a pneumotachometer attached to a transducer the inspiratory and expiratory airflow (l/s) will be measured.

    Measured: 1 hour

  2. EEG

    Using electroencephalogram electrodes C3, C4, O1, F4 to evaluate sleep and wake stages and ground and system reference electrodes (volt)

    Measured: 1 hour

  3. Esophageal pressure

    The pressure of the esophagus measured in cmH2O using an esophageal ballooon catheter.

    Measured: 1 hour

  4. SpO2

    using a pulse oximetry device, to non-invasively measure arterial oxygen saturation level (%).

    Measured: 1 hour

  5. EMG

    Using electromyogram electrodes to evaluate muscular activity (volt)

    Measured: 1 hour

  6. EOG

    electrooculogram electrodes to evaluate rapid eye movements (volt)

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2020
  2. Study start15 Jan 2020
  3. Primary completion27 Oct 2020
  4. Study completion1 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
13 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT04232410
Sponsor's protocol ID
BE300201940940
Acronym
Pcrit-DISE
Status last verified
Jul 2021
First submitted
14 Jan 2020
Last updated
5 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The patient data is coded and only the investigators will have access to the data.

Publications

  • 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.

    PubMed 28364460

  • 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.

    PubMed 8874271

  • 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.

    PubMed 37259138

  • 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.

    PubMed 35112928

Questions about this trial

What is this clinical trial studying?

An observational study of Obstructive Sleep Apnea, run by University Hospital, Antwerp at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Critical closing pressure of the upper airway (Pcrit) (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04232410, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.

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