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

Antwerp University Hospital (UZA)

Status: Completed

Conditions: Obstructive Sleep Apnea

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

Study type: Observational

Funder types: Other

Identifiers

NCT04232410

BE300201940940

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

13 participants in 1 patient group

OSA Pcrit-DISE

Description:

Patients diagnosed with OSA and eligible for non-CPAP treatments

Treatment:

Diagnostic Test: Measurement of critical closing pressure of the uppper airway

Diagnostic Test: Drug induced sleep endoscopy