Multicentre study conducted across centres in the USA, Europe and Australia to assess the safety and effectiveness of a bilateral hypoglossal nerve stimulation system for the treatment of obstructive sleep apnoea in adults: a protocol for a pivotal, multicentre, open-label, single-arm study
Introduction Obstructive sleep apnoea (OSA) is characterised by blood oxygen desaturations and sleep disruptions manifesting undesirable consequences. Existing treatments including oral appliances, positive airway pressure (PAP) therapy and surgically altering the anatomy of the pharynx have drawbac...
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BMJ Publishing Group
2024-12-01
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| Series: | BMJ Open |
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| author | B Tucker Woodson Maria V Suurna M Boyd Gillespie Tod C Huntley Melyssa Hancock Angela Santos Jeyakumar Subbaroyan Fatima Makori Grégoire Fesneau Clemens Heiser David T Kent |
| author_facet | B Tucker Woodson Maria V Suurna M Boyd Gillespie Tod C Huntley Melyssa Hancock Angela Santos Jeyakumar Subbaroyan Fatima Makori Grégoire Fesneau Clemens Heiser David T Kent |
| author_sort | B Tucker Woodson |
| collection | DOAJ |
| description | Introduction Obstructive sleep apnoea (OSA) is characterised by blood oxygen desaturations and sleep disruptions manifesting undesirable consequences. Existing treatments including oral appliances, positive airway pressure (PAP) therapy and surgically altering the anatomy of the pharynx have drawbacks including poor long-term adherence or often involving irreversible, invasive procedures. Bilateral hypoglossal nerve stimulation (HNSBL) is a new treatment for managing OSA, and this study is intended to determine whether an HNSBL system is a safe and effective treatment option for adults with OSA.Methods and analysis This is a pivotal, multicentre, prospective, single-arm study of HNSBL in PAP-intolerant adults with moderate to severe OSA. The device is activated 2 months after implantation with stimulation settings optimised before the final 12-month sleep study. At 12 months, the two coprimary effectiveness endpoints are the percentage of responders based on reduction in the Apnoea-Hypoponea Index, with hypopnoeas associated with 4% oxyhaemoglobin desaturation, and the Oxygen Desaturation Index, using drops in oxygen concentration >4% from baseline (ODI4). Secondary effectiveness endpoints include mean changes in quality-of-life assessments (daytime sleepiness and its effect on activities of daily living, OSA-specific quality of life, daytime sleepiness), levels of intermittent hypoxia, change in hypoxaemic burden and OSA severity.Ethics and dissemination The Food and Drug Administration, Advarra Institutional Review Board (IRB), University of Tennessee HSC IRB, University of Pennsylvania IRB, Weill Cornell Medicine IRB, Medical College of Wisconsin/Froedert Hospital, Human Research Protections Programme Vanderbilt University, St. Vincent’s Hospital Melbourne Human Research Ethics Committee, Ethisch Comite Universitair Ziekenhuis Antwerpen and Technische Universitat Munchen reviewed and approved this protocol. Study results will be disseminated through journal publications, updates to ClinicalTrials.gov and the Nyxoah website, and presentations at meetings and conferences.Trial registration number NCT03868618. |
| format | Article |
| id | doaj-art-154b610a77f341ab94c6f70bb6d1a92b |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-154b610a77f341ab94c6f70bb6d1a92b2025-01-14T17:25:11ZengBMJ Publishing GroupBMJ Open2044-60552024-12-01141210.1136/bmjopen-2024-085218Multicentre study conducted across centres in the USA, Europe and Australia to assess the safety and effectiveness of a bilateral hypoglossal nerve stimulation system for the treatment of obstructive sleep apnoea in adults: a protocol for a pivotal, multicentre, open-label, single-arm studyB Tucker Woodson0Maria V Suurna1M Boyd Gillespie2Tod C Huntley3Melyssa Hancock4Angela Santos5Jeyakumar Subbaroyan6Fatima Makori7Grégoire Fesneau8Clemens Heiser9David T Kent101 Department of Otolaryngology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA2 Department of Otolaryngology-Head and Neck Surgery, University of Miami, Miami, Florida, USA3 Department of Otolaryngology - Head and Neck Surgery, The University of Tennessee Health Science Center College of Medicine, Memphis, Tennessee, USA4 Center for Ear, Nose, Throat, and Allergy, Ascension Medical Group St. Vincent, Carmel, Indiana, USA5 Facial Plastic & Reconstructive Surgery, Nose and Sinus Institute of Boca Raton, Boca Raton, Florida, USA6 Nyxoah SA, Mont-Saint-Guibert, Belgium6 Nyxoah SA, Mont-Saint-Guibert, Belgium7 Inferential Premium Biometry, Paris, France7 Inferential Premium Biometry, Paris, France8 Department of Otorhinolaryngology, Head and Neck Surgery, Technical University of Munich, Munchen, Germany10 Department of Otolaryngology-Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, USAIntroduction Obstructive sleep apnoea (OSA) is characterised by blood oxygen desaturations and sleep disruptions manifesting undesirable consequences. Existing treatments including oral appliances, positive airway pressure (PAP) therapy and surgically altering the anatomy of the pharynx have drawbacks including poor long-term adherence or often involving irreversible, invasive procedures. Bilateral hypoglossal nerve stimulation (HNSBL) is a new treatment for managing OSA, and this study is intended to determine whether an HNSBL system is a safe and effective treatment option for adults with OSA.Methods and analysis This is a pivotal, multicentre, prospective, single-arm study of HNSBL in PAP-intolerant adults with moderate to severe OSA. The device is activated 2 months after implantation with stimulation settings optimised before the final 12-month sleep study. At 12 months, the two coprimary effectiveness endpoints are the percentage of responders based on reduction in the Apnoea-Hypoponea Index, with hypopnoeas associated with 4% oxyhaemoglobin desaturation, and the Oxygen Desaturation Index, using drops in oxygen concentration >4% from baseline (ODI4). Secondary effectiveness endpoints include mean changes in quality-of-life assessments (daytime sleepiness and its effect on activities of daily living, OSA-specific quality of life, daytime sleepiness), levels of intermittent hypoxia, change in hypoxaemic burden and OSA severity.Ethics and dissemination The Food and Drug Administration, Advarra Institutional Review Board (IRB), University of Tennessee HSC IRB, University of Pennsylvania IRB, Weill Cornell Medicine IRB, Medical College of Wisconsin/Froedert Hospital, Human Research Protections Programme Vanderbilt University, St. Vincent’s Hospital Melbourne Human Research Ethics Committee, Ethisch Comite Universitair Ziekenhuis Antwerpen and Technische Universitat Munchen reviewed and approved this protocol. Study results will be disseminated through journal publications, updates to ClinicalTrials.gov and the Nyxoah website, and presentations at meetings and conferences.Trial registration number NCT03868618.https://bmjopen.bmj.com/content/14/12/e085218.full |
| spellingShingle | B Tucker Woodson Maria V Suurna M Boyd Gillespie Tod C Huntley Melyssa Hancock Angela Santos Jeyakumar Subbaroyan Fatima Makori Grégoire Fesneau Clemens Heiser David T Kent Multicentre study conducted across centres in the USA, Europe and Australia to assess the safety and effectiveness of a bilateral hypoglossal nerve stimulation system for the treatment of obstructive sleep apnoea in adults: a protocol for a pivotal, multicentre, open-label, single-arm study BMJ Open |
| title | Multicentre study conducted across centres in the USA, Europe and Australia to assess the safety and effectiveness of a bilateral hypoglossal nerve stimulation system for the treatment of obstructive sleep apnoea in adults: a protocol for a pivotal, multicentre, open-label, single-arm study |
| title_full | Multicentre study conducted across centres in the USA, Europe and Australia to assess the safety and effectiveness of a bilateral hypoglossal nerve stimulation system for the treatment of obstructive sleep apnoea in adults: a protocol for a pivotal, multicentre, open-label, single-arm study |
| title_fullStr | Multicentre study conducted across centres in the USA, Europe and Australia to assess the safety and effectiveness of a bilateral hypoglossal nerve stimulation system for the treatment of obstructive sleep apnoea in adults: a protocol for a pivotal, multicentre, open-label, single-arm study |
| title_full_unstemmed | Multicentre study conducted across centres in the USA, Europe and Australia to assess the safety and effectiveness of a bilateral hypoglossal nerve stimulation system for the treatment of obstructive sleep apnoea in adults: a protocol for a pivotal, multicentre, open-label, single-arm study |
| title_short | Multicentre study conducted across centres in the USA, Europe and Australia to assess the safety and effectiveness of a bilateral hypoglossal nerve stimulation system for the treatment of obstructive sleep apnoea in adults: a protocol for a pivotal, multicentre, open-label, single-arm study |
| title_sort | multicentre study conducted across centres in the usa europe and australia to assess the safety and effectiveness of a bilateral hypoglossal nerve stimulation system for the treatment of obstructive sleep apnoea in adults a protocol for a pivotal multicentre open label single arm study |
| url | https://bmjopen.bmj.com/content/14/12/e085218.full |
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