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NCT Number: NCT04232410

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: 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.

Other names: Pcrit measurement

Primary outcomes

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

    Time frame: 1 hour

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

Secondary outcomes

  1. Airflow

    Time frame: 1 hour

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

  2. EEG

    Time frame: 1 hour

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

  3. Esophageal pressure

    Time frame: 1 hour

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

  4. SpO2

    Time frame: 1 hour

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

  5. EMG

    Time frame: 1 hour

    Using electromyogram electrodes to evaluate muscular activity (volt)

  6. EOG

    Time frame: 1 hour

    electrooculogram electrodes to evaluate rapid eye movements (volt)

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Acronym: Pcrit-DISE

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 18, 2020
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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