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Sleep Apnea, ObstructiveNCT03224936

Propofolsleep - A Study on Cardiopulmonary and Pharyngeal Reactions While Drug Induced Sleep Endoscopy (DISE)

An observational study of Sleep Apnea, Obstructive and Electroencephalography, run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

While Drug Induced Sleep Endoscopy (DISE) in patients with obstructive sleep apnea syndrome (OSAS) apnea and hypopnea occur. Because of the induced phases of apnea in a controlled setting it is possible to evaluate the related pathophysiology of apnea. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PSI
Type of treatment
Medical device
How many people
20 participants
Where
1 siteGermany
Study dates
22 Aug 2017to 31 Dec 2019
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 18 years or older voluntary patients with an obstructive sleep apnea syndrome undergoing elective propofol induced sleep endoscopy at Charité - Universitätsmedizin Berlin Campus Charite Mitte.

Who may be able to join

  • informed written consent
  • age of 18 years or older
  • no participation in other prospective interventional studies
  • OSAS with a polysomnographic shown AHI (apnea-hypopnea-index) of 15/h or more

Who cannot join

  • no written informed consent
  • allergies against study medication
  • ASA (american society of anesthesiologists) class 4 or higher
  • neurodegenerative CNS (central nerve system) or muscle diseases
  • pregnant or breastfeeding patients
  • 25 % or more central or mixed apneas in polysomnography

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charité - Universitätsmedizin Berlin Campus Charité Mitte

    Berlin, State of Berlin, 10115

Other trials in Germany

About this study

Official title: Propofolsleep - A Observational Study on Cardiopulmonary and Pharyngeal Reactions While Drug Induced Sleep Endoscopy in Patients With Obstructive Sleep Apnea Syndrome Under PSI Monitoring

While Drug Induced Sleep Endoscopy (DISE) in patients with obstructive sleep apnea syndrome (OSAS) apnea and hypopnea occur. Because of the induced phases of apnea in a controlled setting it is possible to evaluate the related pathophysiology of apnea. We plan to correlate the Patient State Index (PSI) and other physiologic parameters with phases of apnea and hypopnea.

Read the detailed description

DISE is a standard method in diagnosis of OSAS and its specific localisation and severity. 20 patients with polysomnographic diagnosed OSAS will be enrolled in this prospective observational study. All patients would get a DISE because of the before mentioned reasons (localisation and severity) although they wouldn't participate in this study. They will get a 24-h-RR (blood pressure)-measurement, a transthoracic echocardiography, a peak-flow-test and routine lab examination including troponin and proBNP before the examination. Furthermore they have to fill out the Epworth Sleepiness Scale questionaire.

Before starting the DISE a standard-monitoring (Electrocardiography, pulse oximetry, non-invasive blood pressure, patient state index, near infrared spectroscopy, transcutaneous CO2 (carbon dioxide), invasive blood pressure) will be established. After applying the monitoring the DISE is started by target controlled infusion (Marsh Model) with a sighted goal-concentration of 3.0 µg/ml Propofol in 5 minutes. While the examination a stabile snoring-phase with apnoea/hypopnoea is needed. In this moment a video-endoscopy is started to quantify the level of obstruction. After DISE the sedation will end and the patients will be transported to the recovery room or postanesthesia care unit (PACU). For specific order of events a video recording of the DISE will be realized.

Being tested
PSI
Keywords
DISE, OSAS, PSI
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PSIDevice

    The PSI delivered by Masimo Root (Sedline) will be measured in all patients.

Study groups in NCT03224936
Study groupRoleWhat they receive
DISE groupAll patients in this study group will receive a propofol PSI controlled DISE (drug induced sleep endoscopy).
Receives: Device: PSI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PSI

    Depth of sedation is monitored with a SEDline electroencephalograph based monitor that displays patient state index (PSI).

    Measured: Duration of surgery (an average of 2 hours)

Secondary outcomes (10)

  1. NIRS (near-infrared spectrometry)

    Near-infrared spectrometry in % of left and right hemisphere

    Measured: Duration of surgery (an average of 2 hours)

  2. transcutaneous CO2 (carbon dioxide)

    Measured at the chest.

    Measured: Duration of surgery (an average of 2 hours)

  3. transcutaneous O2 (oxygen)

    Measured at the center of the chest.

    Measured: Duration of surgery (an average of 2 hours)

  4. Propofol

    Total amount of administered propofol.

    Measured: Duration of surgery (an average of 2 hours)

  5. Diaphragma movement

    Diaphragma movement is measured by ultrasound.

    Measured: Duration of surgery (an average of 2 hours)

  6. blood gases

    Arterial blood gas is obtained from an arterial line.

    Measured: Duration of surgery (an average of 2 hours)

  7. heart rate

    by ECG.

    Measured: Duration of surgery (an average of 2 hours)

  8. blood pressure

    NIBP and IBP.

    Measured: Duration of surgery (an average of 2 hours)

  9. TTE (transthoracic echocardiography)

    Parameters of left and right ventricular function, as well as function of heart valves before DISE.

    Measured: shortly before DISE (an average of 30 minutes)

  10. EEG parameters

    Parameters measured by the Sedline monitor

    Measured: Duration of surgery (an average of 2 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2017
  2. Study start22 Aug 2017
  3. Primary completion30 Oct 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03224936
Sponsor's protocol ID
Propofolschlaf
Status last verified
Feb 2025
First submitted
19 Jul 2017
Last updated
14 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Franklin KA, Lindberg E. Obstructive sleep apnea is a common disorder in the population-a review on the epidemiology of sleep apnea. J Thorac Dis. 2015 Aug;7(8):1311-22. doi: 10.3978/j.issn.2072-1439.2015.06.11.

    PubMed 26380759

  • Rivas M, Ratra A, Nugent K. Obstructive sleep apnea and its effects on cardiovascular diseases: a narrative review. Anatol J Cardiol. 2015 Nov;15(11):944-50. doi: 10.5152/AnatolJCardiol.2015.6607.

    PubMed 26574763

  • Drager LF, Togeiro SM, Polotsky VY, Lorenzi-Filho G. Obstructive sleep apnea: a cardiometabolic risk in obesity and the metabolic syndrome. J Am Coll Cardiol. 2013 Aug 13;62(7):569-76. doi: 10.1016/j.jacc.2013.05.045. Epub 2013 Jun 12.

    PubMed 23770180

  • Kaneko Y, Floras JS, Usui K, Plante J, Tkacova R, Kubo T, Ando S, Bradley TD. Cardiovascular effects of continuous positive airway pressure in patients with heart failure and obstructive sleep apnea. N Engl J Med. 2003 Mar 27;348(13):1233-41. doi: 10.1056/NEJMoa022479.

    PubMed 12660387

  • Mansfield DR, Gollogly NC, Kaye DM, Richardson M, Bergin P, Naughton MT. Controlled trial of continuous positive airway pressure in obstructive sleep apnea and heart failure. Am J Respir Crit Care Med. 2004 Feb 1;169(3):361-6. doi: 10.1164/rccm.200306-752OC. Epub 2003 Nov 3.

    PubMed 14597482

  • 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.

    PubMed 24859484

  • 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 24972543

  • Ehsan Z, Mahmoud M, Shott SR, Amin RS, Ishman SL. The effects of anesthesia and opioids on the upper airway: A systematic review. Laryngoscope. 2016 Jan;126(1):270-84. doi: 10.1002/lary.25399. Epub 2015 Jul 21.

    PubMed 26198715

  • Lo YL, Ni YL, Wang TY, Lin TY, Li HY, White DP, Lin JR, Kuo HP. Bispectral Index in Evaluating Effects of Sedation Depth on Drug-Induced Sleep Endoscopy. J Clin Sleep Med. 2015 Sep 15;11(9):1011-20. doi: 10.5664/jcsm.5016.

    PubMed 25979098

  • Hong SD, Dhong HJ, Kim HY, Sohn JH, Jung YG, Chung SK, Park JY, Kim JK. Change of obstruction level during drug-induced sleep endoscopy according to sedation depth in obstructive sleep apnea. Laryngoscope. 2013 Nov;123(11):2896-9. doi: 10.1002/lary.24045. Epub 2013 Aug 5.

    PubMed 23918761

  • Stierer TL, Ishman SL. Bispectral Index in Evaluating Effects of Sedation Depth on Drug-Induced Sleep Endoscopy: DISE or No Dice. J Clin Sleep Med. 2015 Sep 15;11(9):965-6. doi: 10.5664/jcsm.5002. No abstract available.

    PubMed 26285116

  • Chen X, Tang J, White PF, Wender RH, Ma H, Sloninsky A, Kariger R. A comparison of patient state index and bispectral index values during the perioperative period. Anesth Analg. 2002 Dec;95(6):1669-74, table of contents. doi: 10.1097/00000539-200212000-00036.

    PubMed 12456436

  • Schneider G, Mappes A, Neissendorfer T, Schabacker M, Kuppe H, Kochs E. EEG-based indices of anaesthesia: correlation between bispectral index and patient state index? Eur J Anaesthesiol. 2004 Jan;21(1):6-12. doi: 10.1017/s0265021504001024.

    PubMed 14768917

  • Drover D, Ortega HR. Patient state index. Best Pract Res Clin Anaesthesiol. 2006 Mar;20(1):121-8. doi: 10.1016/j.bpa.2005.07.008.

    PubMed 16634419

  • Drover DR, Lemmens HJ, Pierce ET, Plourde G, Loyd G, Ornstein E, Prichep LS, Chabot RJ, Gugino L. Patient State Index: titration of delivery and recovery from propofol, alfentanil, and nitrous oxide anesthesia. Anesthesiology. 2002 Jul;97(1):82-9. doi: 10.1097/00000542-200207000-00012.

    PubMed 12131107

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep Apnea, Obstructive and Electroencephalography, run by Charite University, Berlin, Germany at 1 site in Germany.

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 6 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 14 Feb 2025. 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 Germany. 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?

PSI (time frame: Duration of surgery (an average of 2 hours)). 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 NCT03224936, which also lists 29 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 14 Feb 2025.

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