Clinical trial NCT06372847: DISE-HNS Effect Study
Official title: Assessment of the Effect of Hypoglossal Nerve Stimulation Therapy on the Site of Collapse During DISE
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Hypoglossal nerve stimulation
Drug-induced sleep endoscopy
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Before-and-after study
Primary purpose: BASIC_SCIENCE

Brief 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) 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Δ%area-of-collapse at the level of the lateral walls
timeFrame: Between baseline and one year follow-up
Secondary outcomes:
measure: Δ%area-of-collapse at the level of the palate, tongue base and epiglottis
timeFrame: Between baseline and one year follow-up
measure: Δ%area-of-collapse at each possible site of upper airway collapse (palate, lateral walls, tongue base, epiglottis) in responders and non-responders
timeFrame: Between baseline and one year follow-up
measure: DISE-score during baseline DISE and during one-year follow-up DISE.
timeFrame: At baseline and at one-year follow-up
measure: Non-invasive site and pattern of collapse
timeFrame: At baseline and at one-year follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Department of Otorhinolaryngology and Head & Neck Surgery, Antwerp University Hospital
name: Olivier M Vanderveken, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: Op de Beeck S, Vena D, Mann D, Azarbarzin A, Huyett P, Van de Perck E, Gell LK, Alex RM, Dieltjens M, Willemen M, Verbraecken J, Wellman A, Vanderveken OM, Sands SA. Polysomnographic airflow shapes and site of collapse during drug-induced sleep endoscopy. Eur Respir J. 2024 Jun 6;63(6):2400261. doi: 10.1183/13993003.00261-2024. Print 2024 Jun.
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.
citation: 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.
citation: 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.
citation: 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.