- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06372847
DISE-HNS Effect Study (DISE-HNS)
Assessment of the Effect of Hypoglossal Nerve Stimulation Therapy on the Site of Collapse During DISE
The purpose of this study is to assess the site, pattern and degree of upper airway collapse before and during hypoglossal nerve stimulation (HNS) treatment using clinical standard drug-induced sleep endoscopy (DISE) and using a novel, non-invasive method predicting site of collapse from raw polysomnography (PSG) data.
Furthermore, outcomes will be compared between responders and non-responders.
Study Overview
Status
Conditions
Detailed Description
Patients who will receive hypoglossal nerve stimulation therapy will be recruited at the pre-operative consultation at the department of ENT. As part of the standard procedure, all patients who are eligible for HNS have already undergone DISE.
To be included in the study, the patient should have undergone or is scheduled to undergo a baseline PSG within two years of HNS implantation.
All patients will undergo HNS-implantation and receive HNS-therapy as part of the standard pathway.
One year after HNS-therapy, patients will undergo another PSG as part of routine practice in these patients. An additional DISE will be performed to assess the effect of HNS on the site, pattern and degree of upper airway collapse.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eldar Tukanov, MD
- Phone Number: +32 3 821 82 47
- Email: eldar.tukanov@uza.be
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years or older.
- Eligible for HNS-therapy:
- AHI between 15 and 65 events/hour
- BMI under 32 kg/m2
- Absence of complete concentric collapse of palate (CCC) on DISE
- Intolerance or failure of continuous positive airway pressure (CPAP)-treatment
- Intolerance or failure of mandibular advancement device (MAD)-treatment
- Combination of central and mixed apneas less than 25% of total apneas on recent PSG (not older than two years)
- Scheduled for HNS-implantation at the Antwerp University Hospital
- Capable of giving informed consent
- Baseline polysomnography planned or performed in the last 2 years at the Antwerp University Hospital
Exclusion Criteria:
- Patients will not receive HNS-therapy at the Antwerp University Hospital
- Known medical history of intellectual disability, memory disorders or current psychiatric disorders (psychotic illness, major depression, or acute anxiety attacks as mentioned by the patient).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Receiving hypoglossal nerve stimulation (HNS)
All included patients will be part of this arm.
Patients who are eligible for HNS-therapy for obstructive sleep apnea (OSA) will be invited to participate in the study.
Data from the baseline PSG and baseline DISE as part of the standard pathway for HNS-eligibility will be accessed and collected.
All patients will undergo HNS-implantation and receive HNS-therapy as part of the standard pathway.
After one year of treatment, information from the one-year follow-up PSG as part of the standard pathway will be collected.
Furthermore, patients will undergo an additional one-year follow-up DISE.
|
The hypoglossal nerve stimulation (HNS) implantation and therapy will be performed according to the standard clinical practice without additional procedures.
Information about the surgical procedure will be collected.
HNS implant information and settings will be collected throughout the study until the last study measurement (one year follow-up PSG and DISE) for that patient.
No additional measures or interventions as part of the research project will be performed during implantation or treatment with HNS.
A PSG at one-year follow-up is part of the standard follow-up pathway in patients receiving HNS therapy.
In this study, PSG data will be collected from both baseline and one-year follow-up PSGs to assess treatment effect.
Additionally, PSG data will be used for non-invasive prediction of the site and pattern of collapse using a novel, validated tool developed at our research group.
Drug-induced sleep endoscopy (DISE) is the clinical standard diagnostic test to assess site, pattern and degree of upper-airway collapse in OSA. Baseline DISE is part of the standard clinical pathway for HNS eligibility. In this study, DISE data will be collected from routine baseline DISE without any additional procedures for the patient. They will undergo an additional DISE at one-year follow-up to assess the effect of HNS-therapy on site, pattern and degree of collapse. Both DISEs will be performed according to routine clinical practice in the operating theatre. Sleep will be induced using 1.5 mg bolus injection midazolam and target-controlled propofol infusion (2.0 - 3.0 μg). A flexible fiberoptic nasopharyngoscope will be transnasally inserted. Site, pattern and degree of collapse will be assessed using a standardized scoring system. Other maneuvers, including chin-lift, the use of a simulation bite or lateral position of the head will be performed according to clinical practice. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Δ%area-of-collapse at the level of the lateral walls
Time Frame: Between baseline and one year follow-up
|
The percentage of the area of collapse at the level of the lateral walls - measured using DISE - will be calculated using ImageJ software.
The percentage difference of collapse between baseline and one-year follow-up will be calculated.
|
Between baseline and one year follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Δ%area-of-collapse at the level of the palate, tongue base and epiglottis
Time Frame: Between baseline and one year follow-up
|
The percentage of the area of collapse at the level of the palate, tongue base and epiglottis - measured using DISE - will be calculated using ImageJ software.
The percentage difference of collapse between baseline and one-year follow-up will be calculated.
|
Between baseline and one year follow-up
|
Δ%area-of-collapse at each possible site of upper airway collapse (palate, lateral walls, tongue base, epiglottis) in responders and non-responders
Time Frame: Between baseline and one year follow-up
|
The Δ%area-of-collapse will be specifically identified in the group of responders and the group of non-responders, to compare these two groups.
|
Between baseline and one year follow-up
|
DISE-score during baseline DISE and during one-year follow-up DISE.
Time Frame: At baseline and at one-year follow-up
|
DISE-scores (pattern and degree of collapse at each site of upper airway collapse) will be scored to assess the effect of HNS on this outcome.
|
At baseline and at one-year follow-up
|
Non-invasive site and pattern of collapse
Time Frame: At baseline and at one-year follow-up
|
Non-invasive site and pattern of collapse assessed using the novel developed and validated tool at baseline and 1-year follow-up.
|
At baseline and at one-year follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Olivier M Vanderveken, MD, PhD, Department of Otorhinolaryngology and Head & Neck Surgery, Antwerp University Hospital
Publications and helpful links
General Publications
- Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.
- Sullivan CE, Issa FG, Berthon-Jones M, Eves L. Reversal of obstructive sleep apnoea by continuous positive airway pressure applied through the nares. Lancet. 1981 Apr 18;1(8225):862-5. doi: 10.1016/s0140-6736(81)92140-1.
- Strollo PJ Jr, Soose RJ, Maurer JT, de Vries N, Cornelius J, Froymovich O, Hanson RD, Padhya TA, Steward DL, Gillespie MB, Woodson BT, Van de Heyning PH, Goetting MG, Vanderveken OM, Feldman N, Knaack L, Strohl KP; STAR Trial Group. Upper-airway stimulation for obstructive sleep apnea. N Engl J Med. 2014 Jan 9;370(2):139-49. doi: 10.1056/NEJMoa1308659.
- Sher AE, Schechtman KB, Piccirillo JF. The efficacy of surgical modifications of the upper airway in adults with obstructive sleep apnea syndrome. Sleep. 1996 Feb;19(2):156-77. doi: 10.1093/sleep/19.2.156.
- Levy P, Kohler M, McNicholas WT, Barbe F, McEvoy RD, Somers VK, Lavie L, Pepin JL. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers. 2015 Jun 25;1:15015. doi: 10.1038/nrdp.2015.15.
- 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.
- Somers VK, White DP, Amin R, Abraham WT, Costa F, Culebras A, Daniels S, Floras JS, Hunt CE, Olson LJ, Pickering TG, Russell R, Woo M, Young T; American Heart Association Council for High Blood Pressure Research Professional Education Committee, Council on Clinical Cardiology; American Heart Association Stroke Council; American Heart Association Council on Cardiovascular Nursing; American College of Cardiology Foundation. Sleep apnea and cardiovascular disease: an American Heart Association/american College Of Cardiology Foundation Scientific Statement from the American Heart Association Council for High Blood Pressure Research Professional Education Committee, Council on Clinical Cardiology, Stroke Council, and Council On Cardiovascular Nursing. In collaboration with the National Heart, Lung, and Blood Institute National Center on Sleep Disorders Research (National Institutes of Health). Circulation. 2008 Sep 2;118(10):1080-111. doi: 10.1161/CIRCULATIONAHA.107.189375. Epub 2008 Aug 25. No abstract available. Erratum In: Circulation. 2009 Mar 31;119(12):e380.
- Marshall NS, Wong KK, Cullen SR, Knuiman MW, Grunstein RR. Sleep apnea and 20-year follow-up for all-cause mortality, stroke, and cancer incidence and mortality in the Busselton Health Study cohort. J Clin Sleep Med. 2014 Apr 15;10(4):355-62. doi: 10.5664/jcsm.3600.
- Gottlieb DJ, Punjabi NM. Diagnosis and Management of Obstructive Sleep Apnea: A Review. JAMA. 2020 Apr 14;323(14):1389-1400. doi: 10.1001/jama.2020.3514.
- Vena D, Op de Beeck S, Mann D, et al. Pharyngeal site of collapse and collapsibility estimated from airflow predict oral appliance treatment efficacy. Sleep Medicine. 2022/12/01/ 2022;100:S264-S265. doi:https://doi.org/10.1016/j.sleep.2022.05.713
- Sutherland K, Vanderveken OM, Tsuda H, Marklund M, Gagnadoux F, Kushida CA, Cistulli PA. Oral appliance treatment for obstructive sleep apnea: an update. J Clin Sleep Med. 2014 Feb 15;10(2):215-27. doi: 10.5664/jcsm.3460.
- Vanderveken OM, Beyers J, Op de Beeck S, Dieltjens M, Willemen M, Verbraecken JA, De Backer WA, Van de Heyning PH. Development of a Clinical Pathway and Technical Aspects of Upper Airway Stimulation Therapy for Obstructive Sleep Apnea. Front Neurosci. 2017 Sep 21;11:523. doi: 10.3389/fnins.2017.00523. eCollection 2017.
- Vanderveken OM, Maurer JT, Hohenhorst W, Hamans E, Lin HS, Vroegop AV, Anders C, de Vries N, Van de Heyning PH. Evaluation of drug-induced sleep endoscopy as a patient selection tool for implanted upper airway stimulation for obstructive sleep apnea. J Clin Sleep Med. 2013 May 15;9(5):433-8. doi: 10.5664/jcsm.2658.
- Huyett P, Kent DT, D'Agostino MA, Green KK, Soose RJ, Kaffenberger TM, Woodson BT, Huntley C, Boon MS, Heiser C, Birk A, Suurna MV, Lin HS, Waxman JA, Kezirian EJ. Drug-Induced Sleep Endoscopy and Hypoglossal Nerve Stimulation Outcomes: A Multicenter Cohort Study. Laryngoscope. 2021 Jul;131(7):1676-1682. doi: 10.1002/lary.29396. Epub 2021 Jan 14.
- Nord RS, Fitzpatrick T 4th, Pingree G, Islam A, Chafin A. Should lateral wall collapse be a contraindication for hypoglossal nerve stimulation? Am J Otolaryngol. 2024 Jan-Feb;45(1):104053. doi: 10.1016/j.amjoto.2023.104053. Epub 2023 Sep 24.
- Op de Beeck S, Vena D, Mann D, et al. Identifying the site and pattern of pharyngeal collapse using polysomnographic airflow shapes. Sleep Medicine. 2022/12/01/ 2022;100:S252-S253. doi:https://doi.org/10.1016/j.sleep.2022.05.681
- Op De Beeck S, Vena D, Mann D, et al. Polysomnographic Airflow Shapes and Site of Collapse During Drug-Induced Sleep Endoscopy. C98 DEEP PHENOTYPING FOR SLEEP APNEA THERAPY SUCCESS. American Thoracic Society; 2022:A4817-A4817. American Thoracic Society International Conference Abstracts.
- Safiruddin F, Vanderveken OM, de Vries N, Maurer JT, Lee K, Ni Q, Strohl KP. Effect of upper-airway stimulation for obstructive sleep apnoea on airway dimensions. Eur Respir J. 2015 Jan;45(1):129-38. doi: 10.1183/09031936.00059414. Epub 2014 Sep 3.
- Lou B, Rusk S, Nygate YN, Quintero L, Ishikawa O, Shikowitz M, Greenberg H. Association of hypoglossal nerve stimulator response with machine learning identified negative effort dependence patterns. Sleep Breath. 2023 May;27(2):519-525. doi: 10.1007/s11325-022-02641-y. Epub 2022 May 27.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Project ID 6214
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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