Drug-Induced Sleep Endoscopy for the Optimisation of Treatment of Patients With Obstruction Sleep Apnoea

October 5, 2020 updated by: University Hospital Ostrava

The Role of Drug-Induced Sleep Endoscopy for the Optimisation of Treatment of Patients With Obstruction Sleep Apnoea

The main diagnostic challenge in patients with OSA (obstructive sleep apnea) is to determine the location of obstruction of the upper airway during sleep. This is so, because the otorhinolaryngology examination, which states probable site of obstruction of upper airways, is performed in the awake status. Therefore, drug-induced sleep endoscopy (DISE) has been introduced in the diagnostic algorithm of OSA patients during the last decade. The advantage of DISE is, that the collapse of upper airways, which is not visible during the awake status can be observed and targeted therapy according to the location and degree of obstruction of the upper airway can be applied. As a result, higher treatment success in patients with OSA can be reached.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Materials and Methods The study was approved by the Institutional Ethics Committee and performed in accordance with the Declaration of Helsinki, good clinical practice, and applicable regulatory requirements. Informed written consent was obtained from all participants before initiation of any procedure.

• History, otorhinolaryngology examination, polysomnography Patient history will be taken with emphasis on snoring and OSA symptoms. Daytime sleepiness will be assessed using the Epworth Sleepiness Scale. Moreover, patients will be asked to grade the severity of snoring on a 10-point Visual Analogue Scale (0 = no snoring, 10 = extreme snoring). The body mass index (BMI) will be calculated.

Otorhinolaryngology examination, focusing on nasal, pharyngeal and laryngeal pathologies (enlargement of uvula, soft palate webbing, enlargement of palatal tonsils, base of the tongue hypertrophy, visibility of vallecula, pathology of epiglottis), will be performed.

Thereafter, each patient will undergo polysomnography and patients will be divided according to the severity of OSA into three groups (mild OSA - 5 < AHI ≤ 15, moderate OSA 15 < AHI ≤ 25, and severe OSA with AHI > 25 events per hour of sleep).

According to history, otorhinolaryngology examination and polysomnography, presumably site of obstruction will be stated and therapeutic plan will be designated. Patients with severe OSA will be sent for CPAP (continuous positive airway pressure) treatment, whereas surgery will be recommended for patients with mild and moderate OSA.

• Drug-Induced sleep endoscopy

- Indication and contraindication to DISE DISE will be indicated in patients with mild and moderate OSA and in those with severe OSA who will fail or refuse CPAP treatment. All these patients will be potentially planned for surgery and will have to agree with the surgical treatment.

Patients with ASA (American Society of Anesthesiology) score above 4, as well as patients with central apnea and propofol or midazolam allergies, will be excluded from the study.

  • Premedication Patients will be pre-medicated with a combination of 5 mg midazolam and 0,5 mg atropine intramuscularly 30 minutes before DISE.
  • Procedure Patients will be lying in a supine position on an operation table, the lights will be dimmed and the room quiet to minimize awaking stimuli. Patients will be standardly monitored: ECG (electrocardiogram), blood oxygen saturation, non-invasive blood pressure, and depth of anesthesia will be monitored by bispectral index (BIS). Local anesthesia of nasal cavity will be performed by Lidocaine 10%, 2 sprays into each nostril.

Anaesthesia will be induced by intravenous bolus of propofol 1 mg per kg of ideal body weight, and maintained by repeated boluses of propofol 10-20 mg every 3-5 minutes for the target BIS (Bispectral Index) value of 50-70. Once the patient reaches a satisfactory level of sedation, a flexible fiber optic. Intubation scope 3.7mm x 65cm coated with anti-condense will be introduced into the nasal cavity. The nasal passage, nasopharynx, velum, oropharynx (including tonsils), tongue base, epiglottis, and larynx will be observed. The length of examination will be 15 minutes minimal in order to detect the obstruction. DISE findings will be reported using the VOTE classification system according to Kezirian. Accordingly, localization of upper airways obstructions will be done.

At the end of endoscopy a jaw thrust (or Esmarch maneuver) will be performed. The mandible will be gently advanced up to 5 mm. The manoeuver will be evaluated as successful when the enlargement of upper airway will be observed and disappearance of apnea mimicking the effect of mandibular repositioning appliance (MRA).

After finishing of endoscopy, patients will be awakened to full consciousness in the operating room and then transferred to recovery room for 1-hour observation.

• Evaluation of changes in indication for site of surgery Indication for surgery made according to otorhinolaryngology examination before DISE and after DISE will be compared. Changes will be noted and the number of patients will be calculated using percentage.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 70852
        • University Hospital Ostrava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-65 years
  • obstructive sleep apnoea (mild, moderate Apnea-Hypopnea Index (AHI) <15)
  • severe OSA - failed CPAP treatment
  • severe OSA - patients whorefused CPAP

Exclusion Criteria:

  • ASA 4 (classification of the American Society of Anesthesiologists)
  • pregnancy
  • propofol or midazolam allergies
  • other significant disease with current decompensation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Short-time diagnostic anaesthesia
The study population will consist of patients with obstructive sleep apnoea, which will be classified as mild, moderate, severe (patients who failed or refused primary CPAP treatment). The patients will undergo a short-time general anaesthesia in order to diagnose OSA when relaxed.
Procedure: Short-time diagnostic anaesthesia
Patients will undergo a short-time general anaesthesia in order to diagnose Obstructive Sleep Apnoea when relaxed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of indication for surgery based upon ENT examination before and after DISE.
Time Frame: 36 months
Indication for surgery made according to otorhinolaryngology examination before DISE and after DISE will be compared. There exist a defined number of surgical procedures for which the patient may be indicated, indication for individual surgical procedures will be compared before and after DISE.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Investigators

  • Study Director: Pavel Komínek, prof.MD,PhD,MBA, University Hospital Ostrava
  • Principal Investigator: Jaroslava Hybášková, MD, University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

July 26, 2016

First Submitted That Met QC Criteria

August 1, 2016

First Posted (Estimate)

August 4, 2016

Study Record Updates

Last Update Posted (Actual)

October 6, 2020

Last Update Submitted That Met QC Criteria

October 5, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNO-ENT-DISE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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