Hearing Loss, SensorineuralNCT04881435
Hydrogen-oxygen Gas Mixture Inhalation in Patients With Sudden Sensorineural Hearing Loss
A study testing Hydrogen gas therapy in people with Hearing Loss, Sensorineural, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Idiopathic sudden sensorineural hearing loss (ISSHL) is defined according to American Academy of Otolaryngology as a hearing loss of at least 30 decibel over 3 contiguous test frequencies occurring within a 72h period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- Hydrogen gas therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Jun 2020to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Meet the criteria of definition of sudden sensorineural hearing loss: hearing loss of 30 dB or more over at least three contiguous frequencies, over a period of 72 hours or less.
- The event attacked within 14 days. -
Who cannot join
- pregnancy or other vulnerable groups
- specific etiologies of sudden sensorineural hearing loss
- Diabetes mellitus patients -
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Ching-Nung Wu, MD, 886975369260, taytay@cgmh.org.tw
About this study
Official title: The Effect of Inhaled Hydrogen on the Prognosis of Idiopathic Sudden Sensorineural Hearing Loss
Idiopathic sudden sensorineural hearing loss (ISSHL) is defined according to American Academy of Otolaryngology as a hearing loss of at least 30 decibel over 3 contiguous test frequencies occurring within a 72h period. It affects 5 to 20 people per 100,000 annually and is characterized by sudden-onset, generally unilateral, sensorineural hearing loss. Its cause is idiopathic in most of the patients; however, vascular disorders have been proposed as the final common pathway. Recent studies have reported that the impaired microvascular perfusion occurring during an ischemic event may be related to oxidative stress which may be synergistically responsible for endothelial damage, especially in terminal microvascular systems.
Hydrogen, which serves as a free radical scavenger and can reduce the strong oxidants, is found as a therapeutic gas in cochlea in recent studies. Both antioxidant and anti-inflammatory effects have been seen with hydrogen administration in animal models. Since cisplatinum toxicity and acoustic trauma both involve oxidative stress to the cochlea, hydrogen may prove useful in these conditions. The efficacy and safety of hydrogen inhalation are also proved in clinical studies.
Given the theories mentioned above, the purpose of our study is to use inhaled hydrogen as an adjuvant therapy for treating idiopathic sudden sensorineural hearing loss. The systemic inflammation status and oxidative stress will be monitored. Both subjective and objective efficacy after treatment will be assessed.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- Hydrogen gas therapy
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen gas therapyDevice
Hydrogen gas therapy three times one day for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Hydrogen gas inhalation therapy accompanied with standard steroid treatment | Experimental | Not described Receives: Device: Hydrogen gas therapy |
| Standard steroid treatment | Active comparator | Not described Receives: Device: Hydrogen gas therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
hearing recovery
The level of hearing recovery between the two groups
Measured: 1.before treatment 2. after treatment immediately 3.one month later after treatment
Secondary outcomes (1)
the change of systemic inflammatory status and oxidative stress
Use some indicators of systemic inflammatory status and oxidative stress to measure the changes between the two groups
Measured: 1.before treatment 2. after treatment immediately 3.one month later after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start17 Jun 2020
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ching-Nung Wu, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881435
- Sponsor's protocol ID
- 202000554A3
- Status last verified
- May 2021
- First submitted
- 3 May 2021
- Last updated
- 11 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to sharing currently
Publications
Quaranta N, De Ceglie V, D'Elia A. Endothelial Dysfunction in Idiopathic Sudden Sensorineural Hearing Loss: A Review. Audiol Res. 2016 Jul 27;6(1):151. doi: 10.4081/audiores.2016.151. eCollection 2016 Apr 20.
PubMed 27588164Gode S, Turhal G, Kaya I, Mavili HI, Kirazli T. Evaluation of Procalcitonin and hs-CRP Levels in Sudden Sensorineural Hearing Loss. J Int Adv Otol. 2018 Apr;14(1):44-47. doi: 10.5152/iao.2017.2780. Epub 2017 Jun 21.
PubMed 28639554Capaccio P, Pignataro L, Gaini LM, Sigismund PE, Novembrino C, De Giuseppe R, Uva V, Tripodi A, Bamonti F. Unbalanced oxidative status in idiopathic sudden sensorineural hearing loss. Eur Arch Otorhinolaryngol. 2012 Feb;269(2):449-53. doi: 10.1007/s00405-011-1671-2. Epub 2011 Jun 26.
PubMed 21706323Joachims HZ, Segal J, Golz A, Netzer A, Goldenberg D. Antioxidants in treatment of idiopathic sudden hearing loss. Otol Neurotol. 2003 Jul;24(4):572-5. doi: 10.1097/00129492-200307000-00007.
PubMed 12851547
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inhaled Hydrogen on the Prognosis of Idiopathic Sudden Sensorineural Hearing Loss
- ClinicalTrials.gov ID
- NCT04881435
- Acronym / sponsor ID
- 202000554A3
- Conditions
- Hearing Loss, Sensorineural
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 11 May 2021 (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.
Idiopathic sudden sensorineural hearing loss (ISSHL) is defined according to American Academy of Otolaryngology as a hearing loss of at least 30 decibel over 3 contiguous test frequencies occurring within a 72h period. It affects 5 to 20 people per 100,000 annually and is characterized by sudden-onset, generally unilateral, sensorineural hearing loss. Its cause is idiopathic in most of the patients; however, vascular disorders have been proposed as the final common pathway. Recent studies have reported that the impaired microvascular perfusion occurring during an ischemic event may be related to oxidative stress which may be synergistically responsible for endothelial damage, especially in terminal microvascular systems.
Hydrogen, which serves as a free radical scavenger and can reduce the strong oxidants, is found as a therapeutic gas in cochlea in recent studies. Both antioxidant and anti-inflammatory effects have been seen with hydrogen administration in animal models. Since cisplatinum toxicity and acoustic trauma both involve oxidative stress to the cochlea, hydrogen may prove useful in these conditions. The efficacy and safety of hydrogen inhalation are also proved in clinical studies.
Given the theories mentioned above, the purpose of our study is to use inhaled hydrogen as an adjuvant therapy for treating idiopathic sudden sensorineural hearing loss. The systemic inflammation status and oxidative stress will be monitored. Both subjective and objective efficacy after treatment will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrogen gas inhalation therapy accompanied with standard steroid treatment | Experimental | Device: Hydrogen gas therapy |
| Standard steroid treatment | Active comparator | Device: Hydrogen gas therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Meet the criteria of definition of sudden sensorineural hearing loss: hearing loss of 30 dB or more over at least three contiguous frequencies, over a period of 72 hours or less.
- The event attacked within 14 days. -
Key exclusion criteria (3 listed)
- pregnancy or other vulnerable groups
- specific etiologies of sudden sensorineural hearing loss
- Diabetes mellitus patients -
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 |
|---|---|---|
| Hydrogen gas therapyHydrogen gas therapy three times one day for 5 days | Device | Hydrogen gas inhalation therapy accompanied with standard steroid treatment, Standard steroid treatment |
Primary outcome
hearing recovery
Time frame: 1.before treatment 2. after treatment immediately 3.one month later after treatment
The level of hearing recovery between the two groups
1 secondary outcome
the change of systemic inflammatory status and oxidative stress
Time frame: 1.before treatment 2. after treatment immediately 3.one month later after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Background: PubMed 27588164Quaranta N, De Ceglie V, D'Elia A. Endothelial Dysfunction in Idiopathic Sudden Sensorineural Hearing Loss: A Review. Audiol Res. 2016 Jul 27;6(1):151. doi: 10.4081/audiores.2016.151. eCollection 2016 Apr 20.
- Background: PubMed 28639554Gode S, Turhal G, Kaya I, Mavili HI, Kirazli T. Evaluation of Procalcitonin and hs-CRP Levels in Sudden Sensorineural Hearing Loss. J Int Adv Otol. 2018 Apr;14(1):44-47. doi: 10.5152/iao.2017.2780. Epub 2017 Jun 21.
- Background: PubMed 21706323Capaccio P, Pignataro L, Gaini LM, Sigismund PE, Novembrino C, De Giuseppe R, Uva V, Tripodi A, Bamonti F. Unbalanced oxidative status in idiopathic sudden sensorineural hearing loss. Eur Arch Otorhinolaryngol. 2012 Feb;269(2):449-53. doi: 10.1007/s00405-011-1671-2. Epub 2011 Jun 26.
- Results publication: PubMed 12851547Joachims HZ, Segal J, Golz A, Netzer A, Goldenberg D. Antioxidants in treatment of idiopathic sudden hearing loss. Otol Neurotol. 2003 Jul;24(4):572-5. doi: 10.1097/00129492-200307000-00007.
- Individual participant dataSharing planned: No. no plan to sharing currently
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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. This study is not recruiting at the moment.
Ching-Nung Wu, MD principal investigator
Chang Gung Memorial 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 Hydrogen gas therapy in people with Hearing Loss, Sensorineural, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 May 2021. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ching-Nung Wu, MD (886975369260, taytay@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hearing recovery (time frame: 1.before treatment 2. after treatment immediately 3.one month later after treatment). 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 NCT04881435, which also lists 4 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 11 May 2021.