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Peer-reviewedCC BYBMJ Open

Study protocol of the SuDHO study: hyperbaric oxygen treatment added to standard care for acute idiopathic sudden sensorineural hearing loss – a multicentre randomised controlled trial

  • Kristina Sture Larsen1
  • Frederik Kragerud Goplen1,2
  • Haakon Arnesen3,4
  • Jörg Assmus5
  • Jan Berge1
  • Martin Rygh Braathen6
  • Thomas Evenstad1
  • Matz Elias Kanstad Grimstvedt7
  • Øystein Haugen8
  • Jeanette Hess-Erga1
  • Kathrin Skorpa Nilsen1
  • Mathias Hamlet Næss1
9 more authors
  • Håvard Ottemo Paulsen9
  • Anette Aase Setsaas10
  • Juha Tapio Silvola9,11
  • Einar Solheim12
  • Carl Jacob Sand Solvåg13
  • Anker Stubberud4,14
  • Guro Vaagbø15
  • Natascha Wathne16
  • Bernd Müller15
16 affiliations
  1. 1Department of Otorhinolaryngology and Head and Neck Surgery, Haukeland University Hospital, Bergen, Norway
  2. 2Department of Clinical Medicine, University of Bergen, Bergen, Norway
  3. 3Department of Otorhinolaryngology, St Olavs Hospital/Trondeim University Hospital, Trondheim, Norway
  4. 4Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology (NTNU), Faculty of Medicine and Health Sciences, Trondheim, Norway
  5. 5Centre for Clinical Research, Haukeland University Hospital, Bergen, Norway
  6. 6Department of Anesthesiology, Division of Critical Care, Oslo University Hospital, Oslo, Norway
  7. 7Department of Otorhinolaryngology, Innlandet Hospital Trust, Brumunddal, Norway
  8. 8Department of Otorhinolaryngology, Sørlandet Hospital Trust, Kristiansand, Norway
  9. 9Department of Otorhinolaryngology, Akershus University Hospital, Lørenskog, Norway
  10. 10Department of Otorhinolaryngology, Telemark Hospital Trust, Skien, Telemark, Norway
  11. 11Faculty of Medicine University of Oslo, Campus Ahus, Oslo, Norway
  12. 12Department of Otorhinolaryngology, Helse Førde HF, Førde, Sogn og Fjordane, Norway
  13. 13Department of Otorhinolaryngology, Østfold Hospital Trust, Kalnes, Norway
  14. 14Department of Otorhinolaryngology, Helse Møre og Romsdal HF, Ålesund, Møre og Romsdal, Norway
  15. 15Hyperbaric Medicine Unit, Department of Occupational Medicine, Haukeland University Hospital, Bergen, Norway
  16. 16Department of Otorhinolaryngology and Head and Neck Surgery, Stavanger University Hospital, Stavanger, Norway
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Abstract

Introduction Idiopathic sudden sensorineural hearing loss (ISSNHL) can lead to permanent sequelae with functional impairment of hearing. Hyperbaric oxygen treatment (HBOT) may improve outcomes but conclusive evidence for its efficacy is currently lacking.Methods and analysis This is a multicentre, 1:1 randomised, controlled, assessor-blind trial comparing standard care alone versus HBOT plus standard care. Adult patients with ISSNHL, at least 50 dB hearing level (HL) in pure tone average (PTA4) on the affected ear and who were eligible for commencement of HBOT within 7 days from onset of hearing loss are included. Those with other causes of hearing loss and contraindications for HBOT are excluded. The primary outcome is absolute PTA4 after 14 weeks, while secondary outcomes include other measures of audiometric hearing improvement including word recognition score and patient-reported outcomes related to hearing, tinnitus, balance and quality of life. The power analyses indicated a group size of 151 participants to detect a difference in mean PTA4 of at least 10 dB HL at follow-up with 90% power based on an assumed SD of 34 dB HL with a 0.05 significance level.Ethics and dissemination The trial has been approved by the Regional committees for medical and health research ethics (268140), by the Norwegian Medical Products Agency and is registered in the EU Clinical Trials Information System (CTIS, 2024-510798-84-00). User representatives have been involved in the development of the study. The results will be reported according to the Consolidated Standards of Reporting Trials (CONSORT) 2025 guidelines in an international peer-reviewed medical journal as soon as possible after the last visit of the last patient.Trial registration number 2021-002284-22 (primary registration 4 May 2021; initially registered in EU Clinical Trials Register (EudraCT)). From 2024 replaced by EU Clinical Trials Information System (CTIS): 2024-510798-84-00 (primary registration 2 October 2024).

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Cite

BibTeXRIS
BibTeX
@article{larsen2026study,
  title = {{Study protocol of the SuDHO study: hyperbaric oxygen treatment added to standard care for acute idiopathic sudden sensorineural hearing loss – a multicentre randomised controlled trial}},
  author = {Kristina Sture Larsen and Frederik Kragerud Goplen and Haakon Arnesen and Jörg Assmus and Jan Berge and Martin Rygh Braathen and Thomas Evenstad and Matz Elias Kanstad Grimstvedt and Øystein Haugen and Jeanette Hess-Erga and Kathrin Skorpa Nilsen and Mathias Hamlet Næss and Håvard Ottemo Paulsen and Anette Aase Setsaas and Juha Tapio Silvola and Einar Solheim and Carl Jacob Sand Solvåg and Anker Stubberud and Guro Vaagbø and Natascha Wathne and Bernd Müller},
  journal = {BMJ Open},
  year = {2026},
  month = nov,
  doi = {10.1136/bmjopen-2026-121315},
  url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-121315},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Study protocol of the SuDHO study: hyperbaric oxygen treatment added to standard care for acute idiopathic sudden sensorineural hearing loss – a multicentre randomised controlled trial
AU  - Kristina Sture Larsen
AU  - Frederik Kragerud Goplen
AU  - Haakon Arnesen
AU  - Jörg Assmus
AU  - Jan Berge
AU  - Martin Rygh Braathen
AU  - Thomas Evenstad
AU  - Matz Elias Kanstad Grimstvedt
AU  - Øystein Haugen
AU  - Jeanette Hess-Erga
AU  - Kathrin Skorpa Nilsen
AU  - Mathias Hamlet Næss
AU  - Håvard Ottemo Paulsen
AU  - Anette Aase Setsaas
AU  - Juha Tapio Silvola
AU  - Einar Solheim
AU  - Carl Jacob Sand Solvåg
AU  - Anker Stubberud
AU  - Guro Vaagbø
AU  - Natascha Wathne
AU  - Bernd Müller
PY  - 2026
DA  - 2026/11/04
JO  - BMJ Open
DO  - 10.1136/bmjopen-2026-121315
UR  - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-121315
AB  - Introduction Idiopathic sudden sensorineural hearing loss (ISSNHL) can lead to permanent sequelae with functional impairment of hearing. Hyperbaric oxygen treatment (HBOT) may improve outcomes but conclusive evidence for its efficacy is currently lacking.Methods and analysis This is a multicentre, 1:1 randomised, controlled, assessor-blind trial comparing standard care alone versus HBOT plus standard care. Adult patients with ISSNHL, at least 50 dB hearing level (HL) in pure tone average (PTA4) on the affected ear and who were eligible for commencement of HBOT within 7 days from onset of hearing loss are included. Those with other causes of hearing loss and contraindications for HBOT are excluded. The primary outcome is absolute PTA4 after 14 weeks, while secondary outcomes include other measures of audiometric hearing improvement including word recognition score and patient-reported outcomes related to hearing, tinnitus, balance and quality of life. The power analyses indicated a group size of 151 participants to detect a difference in mean PTA4 of at least 10 dB HL at follow-up with 90% power based on an assumed SD of 34 dB HL with a 0.05 significance level.Ethics and dissemination The trial has been approved by the Regional committees for medical and health research ethics (268140), by the Norwegian Medical Products Agency and is registered in the EU Clinical Trials Information System (CTIS, 2024-510798-84-00). User representatives have been involved in the development of the study. The results will be reported according to the Consolidated Standards of Reporting Trials (CONSORT) 2025 guidelines in an international peer-reviewed medical journal as soon as possible after the last visit of the last patient.Trial registration number 2021-002284-22 (primary registration 4 May 2021; initially registered in EU Clinical Trials Register (EudraCT)). From 2024 replaced by EU Clinical Trials Information System (CTIS): 2024-510798-84-00 (primary registration 2 October 2024).
SN  - 2044-6055
SN  - 2044-6055
ER  -