Obstructive Sleep ApnoeaNCT02855515
Drug-Induced Sleep Endoscopy for the Optimisation of Treatment of Patients With Obstruction Sleep Apnoea
A study testing Short-time diagnostic anaesthesia in people with Obstructive Sleep Apnoea and Sleep-Disordered Breathing, run by University Hospital Ostrava at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnoea, Sleep-Disordered Breathing
- What is being tested?
- Short-time diagnostic anaesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCzechia
- Study dates
- May 2016to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years
- obstructive sleep apnoea (mild, moderate Apnea-Hypopnea Index (AHI) <15)
- severe OSA - failed CPAP treatment
- severe OSA - patients whorefused CPAP
Who cannot join
- ASA 4 (classification of the American Society of Anesthesiologists)
- pregnancy
- propofol or midazolam allergies
- other significant disease with current decompensation
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
About this study
Official title: 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.
Read the 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.
- Being tested
- Short-time diagnostic anaesthesia
- Keywords
- drug-induced sleep endoscopy, obstructive sleep apnoea, VOTE classification, AHI, BMI
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-time diagnostic anaesthesiaProcedure or surgery
Patients will undergo a short-time general anaesthesia in order to diagnose Obstructive Sleep Apnoea when relaxed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Short-time diagnostic anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApnoeaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pavel Komínek, prof.MD,PhD,MBA, Study director, University Hospital OstravaJaroslava Hybášková, MD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855515
- Sponsor's protocol ID
- FNO-ENT-DISE
- Status last verified
- Oct 2020
- First submitted
- 26 Jul 2016
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 24972543Campanini 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.
PubMed 20559476Cavaliere 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.
PubMed 24167821DE 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.
PubMed 24376297De 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.
PubMed 24859484Kezirian 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.
PubMed 21614467
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Drug-Induced Sleep Endoscopy for the Optimisation of Treatment of Patients With Obstruction Sleep Apnoea
- ClinicalTrials.gov ID
- NCT02855515
- Acronym / sponsor ID
- FNO-ENT-DISE
- Keywords
- drug-induced sleep endoscopy, obstructive sleep apnoea, VOTE classification, AHI, BMI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Short-time diagnostic anaesthesia | Experimental | Procedure: Short-time diagnostic anaesthesiaThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years
- obstructive sleep apnoea (mild, moderate Apnea-Hypopnea Index (AHI) <15)
- severe OSA - failed CPAP treatment
- severe OSA - patients whorefused CPAP
Key exclusion criteria (4 listed)
- ASA 4 (classification of the American Society of Anesthesiologists)
- pregnancy
- propofol or midazolam allergies
- other significant disease with current decompensation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short-time diagnostic anaesthesiaPatients will undergo a short-time general anaesthesia in order to diagnose Obstructive Sleep Apnoea when relaxed. | Procedure or surgery | Short-time diagnostic anaesthesia |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Background: PubMed 24972543Aktas 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.
- Background: PubMed 20559476Campanini 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.
- Background: PubMed 24167821Cavaliere 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.
- Background: PubMed 24376297DE 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.
- Background: PubMed 24859484De 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.
- Background: PubMed 21614467Kezirian 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pavel Komínek, prof.MD,PhD,MBA study director
University Hospital Ostrava
Jaroslava Hybášková, MD principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short-time diagnostic anaesthesia in people with Obstructive Sleep Apnoea and Sleep-Disordered Breathing, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of indication for surgery based upon ENT examination before and after DISE. (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02855515, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.