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

NCT02855515 | Completed

• 1 other identifier: FNO-ENT-DISE
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnoea; Sleep-Disordered Breathing

Keywords

drug-induced sleep endoscopy; obstructive sleep apnoea; VOTE classification; AHI; BMI

Outcome Measures

Primary Outcomes (1)

• Comparison of indication for surgery based upon ENT examination before and after DISE.

  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

Study Arms (1)

Short-time diagnostic anaesthesia

EXPERIMENTAL

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

Interventions

Short-time diagnostic anaesthesia PROCEDURE

Patients will undergo a short-time general anaesthesia in order to diagnose Obstructive Sleep Apnoea when relaxed.

Short-time diagnostic anaesthesia

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

Related Publications (6)

• Aktas O, Erdur O, Cirik AA, Kayhan FT. The role of drug-induced sleep endoscopy in surgical planning for obstructive sleep apnea syndrome. Eur Arch Otorhinolaryngol. 2015 Aug;272(8):2039-43. doi: 10.1007/s00405-014-3162-8. Epub 2014 Jun 28.

  PMID: 24972543 BACKGROUND

• Campanini A, Canzi P, De Vito A, Dallan I, Montevecchi F, Vicini C. Awake versus sleep endoscopy: personal experience in 250 OSAHS patients. Acta Otorhinolaryngol Ital. 2010 Apr;30(2):73-7.

  PMID: 20559476 BACKGROUND

• Cavaliere M, Russo F, Iemma M. Awake versus drug-induced sleep endoscopy: evaluation of airway obstruction in obstructive sleep apnea/hypopnoea syndrome. Laryngoscope. 2013 Sep;123(9):2315-8. doi: 10.1002/lary.23881.

  PMID: 24167821 BACKGROUND

• DE Corso E, Fiorita A, Rizzotto G, Mennuni GF, Meucci D, Giuliani M, Marchese MR, Levantesi L, Della Marca G, Paludetti G, Scarano E. The role of drug-induced sleep endoscopy in the diagnosis and management of obstructive sleep apnoea syndrome: our personal experience. Acta Otorhinolaryngol Ital. 2013 Dec;33(6):405-13.

  PMID: 24376297 BACKGROUND

• De Vito A, Carrasco Llatas M, Vanni A, Bosi M, Braghiroli A, Campanini A, de Vries N, Hamans E, Hohenhorst W, Kotecha BT, Maurer J, Montevecchi F, Piccin O, Sorrenti G, Vanderveken OM, Vicini C. European position paper on drug-induced sedation endoscopy (DISE). Sleep Breath. 2014 Sep;18(3):453-65. doi: 10.1007/s11325-014-0989-6. Epub 2014 May 26.

  PMID: 24859484 BACKGROUND

• Kezirian EJ, Hohenhorst W, de Vries N. Drug-induced sleep endoscopy: the VOTE classification. Eur Arch Otorhinolaryngol. 2011 Aug;268(8):1233-1236. doi: 10.1007/s00405-011-1633-8. Epub 2011 May 26.

  PMID: 21614467 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

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

Study Officials

• Pavel Komínek, prof.MD,PhD,MBA

  University Hospital Ostrava

  STUDY DIRECTOR

• Jaroslava Hybášková, MD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: August 4, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: June 1, 2019
• Last Updated: October 6, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)