Sleep-Disordered Breathing Clinical Trial
Official title:
The Role of Drug-Induced Sleep Endoscopy for the Optimisation of Treatment of Patients With Obstruction Sleep Apnoea
NCT number | NCT02855515 |
Other study ID # | FNO-ENT-DISE |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | June 2019 |
Verified date | October 2020 |
Source | University Hospital Ostrava |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | June 2019 |
Est. primary completion date | May 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Czechia | University Hospital Ostrava | Ostrava | Moravian-Silesian Region |
Lead Sponsor | Collaborator |
---|---|
University Hospital Ostrava |
Czechia,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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