Obstructive Sleep ApneaDISE-HNSNCT06372847
DISE-HNS Effect Study
A study testing Hypoglossal nerve stimulation implant, Polysomnography and Drug-induced sleep endoscopy (DISE) in people with Obstructive Sleep Apnea, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Hypoglossal nerve stimulation implant, Polysomnography and Drug-induced sleep endoscopy (DISE)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Oct 2025to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, Antwerpen, 2650
Ethical Committee, +32 3 821 38 97, ethisch.comite@uza.be
About this study
Official title: 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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Hypoglossal nerve stimulation implant, Polysomnography, Drug-induced sleep endoscopy (DISE)
- Keywords
- Hypoglossal nerve stimulation, Drug-induced sleep endoscopy
- 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.
Hypoglossal nerve stimulation implantDevice
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.
PolysomnographyDiagnostic test
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)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Receiving hypoglossal nerve stimulation (HNS) | Other | 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. Receives: Device: Hypoglossal nerve stimulation implant; Diagnostic Test: Polysomnography; Procedure: Drug-induced sleep endoscopy (DISE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Δ%area-of-collapse at the level of the lateral walls
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.
Measured: Between baseline and one year follow-up
Secondary outcomes (4)
Δ%area-of-collapse at the level of the palate, tongue base and epiglottis
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.
Measured: 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
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.
Measured: Between baseline and one year follow-up
DISE-score during baseline DISE and during one-year follow-up DISE.
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.
Measured: At baseline and at one-year follow-up
Non-invasive site and pattern of collapse
Non-invasive site and pattern of collapse assessed using the novel developed and validated tool at baseline and 1-year follow-up.
Measured: At baseline and at one-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start21 Oct 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Before-and-after study
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier M Vanderveken, MD, PhD, Principal investigator, Department of Otorhinolaryngology and Head & Neck Surgery, Antwerp University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372847
- Sponsor's protocol ID
- Project ID 6214
- Acronym
- DISE-HNS
- Status last verified
- Nov 2025
- First submitted
- 25 Mar 2024
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will solely be available to members of the A-SLEAP research team (Antwerp University Hospital and University of Antwerp, led by the principal investigator of this study). Data will not be shared outside of the research team or the affiliated organizations.
Publications
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.
PubMed 27188535Somers 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.
PubMed 18725495Marshall 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.
PubMed 24733978Gottlieb 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.
PubMed 32286648Marin 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.
PubMed 15781100Sullivan 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.
PubMed 6112294Vena 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.
PubMed 24533007Vanderveken 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.
PubMed 28983236Strollo 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.
PubMed 24401051Vanderveken 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.
PubMed 23674933Huyett 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.
PubMed 33443811Nord 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.
PubMed 37769502Op 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Hypoglossal Nerve Stimulation Therapy on the Site of Collapse During DISE
- ClinicalTrials.gov ID
- NCT06372847
- Acronym / sponsor ID
- DISE-HNS / Project ID 6214
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Hypoglossal nerve stimulation, Drug-induced sleep endoscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 18 Apr 2024 (actual)
- 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 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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before-and-after study
| Arm | Type | Receives |
|---|---|---|
| Receiving hypoglossal nerve stimulation (HNS) | Other | Device: Hypoglossal nerve stimulation implant, Diagnostic Test: Polysomnography, Procedure: Drug-induced sleep endoscopy (DISE)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (2 listed)
- 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).
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 |
|---|---|---|
| Hypoglossal nerve stimulation implantThe 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. | Device | Receiving hypoglossal nerve stimulation (HNS) |
| PolysomnographyA 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. | Diagnostic test | Receiving hypoglossal nerve stimulation (HNS) |
| Drug-induced sleep endoscopy (DISE)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. | Procedure or surgery | Receiving hypoglossal nerve stimulation (HNS) |
Primary outcome
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.
4 secondary outcomes
Δ%area-of-collapse at the level of the palate, tongue base and epiglottis
Time frame: 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
DISE-score during baseline DISE and during one-year follow-up DISE.
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Background: PubMed 27188535Levy 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.
- Background: PubMed 18725495Somers 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.
- Background: PubMed 24733978Marshall 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.
- Background: PubMed 32286648Gottlieb 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.
- Background: PubMed 15781100Marin 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.
- Background: PubMed 6112294Sullivan 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.
- BackgroundVena 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
- Background: PubMed 24533007Sutherland 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.
- Background: PubMed 28983236Vanderveken 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.
- Background: PubMed 24401051Strollo 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.
- Background: PubMed 23674933Vanderveken 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.
- Background: PubMed 33443811Huyett 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.
- Individual participant dataSharing planned: No. All data will solely be available to members of the A-SLEAP research team (Antwerp University Hospital and University of Antwerp, led by the principal investigator of this study). Data will not be shared outside of the research team or the affiliated organizations.
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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.
Olivier M Vanderveken, MD, PhD principal investigator
Department of Otorhinolaryngology and Head & Neck Surgery, Antwerp University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoglossal nerve stimulation implant, Polysomnography and Drug-induced sleep endoscopy (DISE) in people with Obstructive Sleep Apnea, run by University Hospital, Antwerp at 1 site in Belgium.
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 11 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 3 Dec 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eldar Tukanov, MD (+32 3 821 82 47, eldar.tukanov@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Δ%area-of-collapse at the level of the lateral walls (time frame: Between baseline and one year follow-up). 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 NCT06372847, which also lists 19 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 3 Dec 2025.