Clinical trial • Phase II/III • Other
Nitrous oxide, Oxygen for Idiopathic sudden sensorineural hearing loss
Phase II/III trial of Nitrous oxide, Oxygen for Idiopathic sudden sensorineural hearing loss.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Idiopathic sudden sensorineural hearing loss
- Trial Stage
- Phase II/III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 02-10-2024
- First CTIS Authorization Date
- 13-10-2024
Trial design
Randomised, intervention: standard care plus hyperbaric oxygen treatment (hbo) according to diving table 14/90 (100% oxygen, 90 minutes, 2,4 ata pressure), once daily for 15 days. control: standard care. Phase II/III trial in Norway.
- Randomised
- Yes
- Comparator
- Intervention: Standard care plus Hyperbaric oxygen treatment (HBO) according to diving table 14/90 (100% oxygen, 90 minutes, 2,4 ATA pressure), once daily for 15 days. Control: Standard care.
- Target Sample Size
- 490
- Trial Duration For Participant
- 98
Eligibility
Recruits 490 Vulnerable population not selected; participants are adults (18 to 80 years); informed consent is from adult participants only; no paediatric assent procedures described..
- Pregnancy Exclusion
- Pregnancy
- Vulnerable Population
- Vulnerable population not selected; participants are adults (18 to 80 years); informed consent is from adult participants only; no paediatric assent procedures described.
Inclusion criteria
- {"criterion_text":"- 18 to 80 years of age"}
- {"criterion_text":"- Onset of acute hearing loss no longer than 7 days ago"}
- {"criterion_text":"- HBO can be started within 7 days from symptom onset"}
- {"criterion_text":"- Pure tone audiometry shows sensorineural hearing loss with at least 30dB loss in three consecutive frequencies"}
- {"criterion_text":"- Idiopathic sensorineural hearing loss is the most probable diagnosis according to clinical judgement"}
- {"criterion_text":"- The hearing threshold is 50 dB or more in PTA (based on 0,5kHz, 1kHz, 2kHz, 4kHz)"}
Exclusion criteria
- {"criterion_text":"- Not idiopathic sudden sensorineural hearing loss, but another disease, injury or condition is most likely the cause of the current hearing loss."}
- {"criterion_text":"- Cognitive or language barriers that hamper adherence to the study protocol 3. Major"}
- {"criterion_text":"- Major alcohol abuse"}
- {"criterion_text":"- Any contraindication to treatment with hyperbaric oxygen: -\tCOPD, asthma or other lung disease with severely reduced lung function corresponding to GOLD III (spirometry shows FEV1 <50% of expected) -\tAsthma not well regulated on oral basic medication and/or with attacks within the last year -\tCurrent pneumonia or <4 weeks from complete recovery -\tX-ray showing emphysema-bulla or non-static atelectasis -\tSevere cardiac failure, instable angina, cardial infarction <6 months ago -\tOngoing use of Disulfiram (Antabus ®) -\tEarlier treatment with Bleomycin (any time) -\tArtificial middle ear bones -\tPregnancy"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Mean absolute pure tone average (PTA*) at week 14 *PTA=mean hearing-threshold in dB of the 4 frequencies 0,5 kHz, 1kHz, 2kHz and 4kHz","definition_or_measurement_approach":"PTA = mean hearing-threshold in dB of the 4 frequencies 0.5 kHz, 1 kHz, 2 kHz and 4 kHz; measured at week 14."}
Secondary endpoints
- {"endpoint_text":"- Mean change in PTA (dB) from baseline to week 14","definition_or_measurement_approach":"Change in PTA (dB) from baseline to week 14."}
- {"endpoint_text":"- Proportion of patients with improvement of at least 10dB PTA from baseline to week 14","definition_or_measurement_approach":"Proportion of patients achieving >=10 dB improvement in PTA between baseline and week 14."}
- {"endpoint_text":"- Mean word recognition score (WRS) in percentage-points at week 14 and change from baseline","definition_or_measurement_approach":"Mean WRS (%) at week 14 and change from baseline (word recognition testing)."}
- {"endpoint_text":"- Categories of hearing recovery according to Siegel's criteria at week 14","definition_or_measurement_approach":"Hearing recovery categorized by Siegel's criteria at week 14."}
- {"endpoint_text":"- Categories of hearing-loss severity and proportion of patients with serviceable hearing according to the AAO-HNS criteria at baseline and week 14","definition_or_measurement_approach":"Hearing-loss severity categories and proportion with serviceable hearing per AAO-HNS criteria at baseline and week 14."}
- {"endpoint_text":"- Total score of patient reported communication problems assessed by APHAB-questionnaire at day 1 and week 14","definition_or_measurement_approach":"Total APHAB questionnaire score at day 1 and week 14 (patient-reported communication problems)."}
- {"endpoint_text":"- RAND-12 scores at day 1 and week 14","definition_or_measurement_approach":"RAND-12 health-related quality of life scores at day 1 and week 14."}
- {"endpoint_text":"- Adverse events (AE) and serious AEs (SAE)","definition_or_measurement_approach":"Recording and reporting of adverse events and serious adverse events throughout the study."}
- {"endpoint_text":"- Known side-effects of HBOT","definition_or_measurement_approach":"Monitoring and recording of known hyperbaric oxygen therapy side-effects."}
- {"endpoint_text":"- Mean APHAB score at week 14","definition_or_measurement_approach":"Mean APHAB score at week 14 (patient-reported communication problems)."}
Recruitment
- Planned Sample Size
- 490
- Recruitment Window Months
- 71
- Consent Approach
- Informed consent obtained from adult participants (document: L1_SIS and ICF adults). Participants are aged 18-80; no paediatric assent described. Languages of consent documents not specified.
Geography
- Total Number Of Sites
- 12
- Total Number Of Participants
- 490
Norway
- Earliest CTIS Part Ii Submission Date
- 16-02-2024
- Latest Decision Or Authorization Date
- 23-05-2025
- Processing Time Days
- 462
- Number Of Sites
- 12
- Number Of Participants
- 490
Sites
- Site Name
- Helse Stavanger HF
- Department Name
- Øre-nese-hals avdeling
- Contact Person Name
- Natascha Wathne
- Contact Person Email
- Natascha.wathne@sus.no
- Site Name
- Helse Forde HF
- Department Name
- Øre-nese-hals og kjeve avdeling
- Contact Person Name
- Einar Solheim
- Contact Person Email
- einar.solheim@helse-forde.no
- Site Name
- St. Olavs Hospital HF
- Department Name
- Avdeling for øre-nese-hals
- Contact Person Name
- Håkon Arnesen
- Contact Person Email
- Haakon.arnesen@stolav.no
- Site Name
- Helse Moere Og Romsdal HF
- Department Name
- Øre-nese-hals avdelingen
- Contact Person Name
- Anker Stubberud
- Contact Person Email
- anker.stubberud@helse-mr.no
- Site Name
- Akershus University Hospital
- Department Name
- Øre-nese-hals avdeling
- Contact Person Name
- Juha Silvola
- Contact Person Email
- j.t.silvola@medisin.uio.no
- Site Name
- Drammen Sykehus
- Department Name
- Øre-nese-hals avdeling
- Contact Person Name
- Hans Kristian Røkenes
- Contact Person Email
- hans.kristian.rokenes@vestreviken.no
- Site Name
- Sykehuset Telemark HF
- Department Name
- Øre-nes-hals avdeling
- Contact Person Name
- Anette Aase Setsaas
- Contact Person Email
- aneaas@sthf.no
- Site Name
- Helse Bergen HF
- Department Name
- Dep. of Otolaryngology, head and neck sugery
- Contact Person Name
- Frederik Goplen
- Contact Person Email
- Frederik.kragerud.goplen@helse-bergen.no
- Site Name
- Oslo University Hospital HF
- Department Name
- Dep. of Anesthesiology, OUS-Ullevål
- Contact Person Name
- Ine Røed
- Contact Person Email
- uxredi@ous-hf.no
- Site Name
- Sorlandet Sykehus HF
- Department Name
- Øre-nese-hals avdelingen
- Contact Person Name
- Øystein Haugen
- Contact Person Email
- oystein.haugen@sshf.no
- Site Name
- Sykehuset Innlandet HF
- Department Name
- Øre-nese-hals avdeling
- Contact Person Name
- Matz Grimstvedt
- Contact Person Email
- matgri@sihf.no
- Site Name
- Sykehuset Oestfold HF Kalnes
- Department Name
- Øre-nese-hals avdeling
- Contact Person Name
- Carl Jacob Solvaag
- Contact Person Email
- carl.jacob.sand.solvag@so-hf.no
Sponsor
Primary sponsor
- Full Name
- Helse Bergen HF
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Norway
Investigational products
- Investigational Product Name
- OXYGEN
- Active Substance
- Nitrous oxide, Oxygen
- Modality
- Small molecule
- Routes Of Administration
- Inhalation (gas)
- Route
- Inhalation (gas)
- Starting Dose
- 100% oxygen, 90 minutes, 2.4 ATA (per protocol: diving table 14/90)
- Frequency
- Once daily for 15 days
- Maximum Dose
- Product fields: maxDailyDoseAmount 95 min; maxTotalDoseAmount 1520 min
- Combination Treatment
- Yes
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