Sudden Sensorineural Hearing Loss (SSNHL)NCT06819202
Effect of Hyperbaric Oxygen Therapy(HBOT) on Patients With Sudden Sensorineural Hearing Loss(SSNHL) and Coagulation Function
An observational study of Sudden Sensorineural Hearing Loss (SSNHL) and Hyperbaric Oxygen Therapy, run by Sun Yuting at 1 site in China.
Trial summary
The objective of this observational study was to understand the effect of HBO on patients with SSNHL and its association with coagulation function and prognosis. The main question it aims to answer is whether HBO therapy can improve outcomes and coagulation function in patients with SSNHL. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sudden Sensorineural Hearing Loss (SSNHL), Hyperbaric Oxygen Therapy
- What is being tested?
- Hyperbaric oxygen treatment
- How many people
- 1,309 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From January 2022 to September 2024, in Putuo Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Otolaryngology Hospital Affiliated to Fudan University, Xinhua Hospital affiliated to Shanghai Jiao Tong University or Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, treating patients with sudden sensorineural deafness.
Who may be able to join
- Meet the diagnostic criteria for sudden deafness in the American Academy of Otolaryngology Head and Neck Surgery 2019 Clinical Practice Guidelines for Sudden Deafness;
- Aged 18-75 years old;
- Patients with unilateral sudden deafness for the first time, and the onset time is less than 2 weeks.
Who cannot join
- Patients with other ear diseases, such as auditory trauma, barotrauma, retrocochlear disease, bilateral hearing loss, history of chronic otitis media in the same ear, and history of surgery in the same ear;
- Patients with serious primary diseases such as heart, liver, kidney dysfunction and hematopoietic system diseases;
- Pregnant and nursing patients;
- Accompanied by serious mental illness;
- Patients with incomplete clinical data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai University of Traditional Chinese Medicine
Shanghai, Putuo, 200333
Sun YT Sun, PhD student, 19821758594, syt_354@163.com
About this study
Official title: Effect of Hyperbaric Oxygen Therapy on Patients With Sudden Sensorineural Hearing Loss and Coagulation Function
The objective of this observational study was to understand the effect of HBO on patients with SSNHL and its association with coagulation function and prognosis.
The main question it aims to answer is whether HBO therapy can improve outcomes and coagulation function in patients with SSNHL.
The prognosis of SSNHL patients receiving HBO and SSNHL patients not receiving HBO were compared
- Being tested
- Hyperbaric oxygen treatment
- Medical subject headings
- Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen treatmentOther
HBO therapy is the process of inhaling 100% pure oxygen in an environment above one atmosphere (pressure range: 2.0-3.0 absolute atmospheres) to treat a disease.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing recovery rate
The rate of hearing recovery in patients with all levels of hearing loss at completion of treatment and at 3 months after termination of treatment was assessed according to the WHO Hearing Loss Rating Criteria 2021 to determine the success of treatment.
Measured: From onset to 3 months 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 Feb 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Sensorineural Hearing Loss (SSNHL)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,309 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yuting
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sun Yuting, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819202
- Sponsor's protocol ID
- PTEC-A-2025-1(S)-1
- Status last verified
- May 2025
- First submitted
- 25 Jan 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hyperbaric Oxygen Therapy on Patients With Sudden Sensorineural Hearing Loss and Coagulation Function
- ClinicalTrials.gov ID
- NCT06819202
- Acronym / sponsor ID
- PTEC-A-2025-1(S)-1
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,309 participants (estimated)
- Lead sponsor
- Sun YutingUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 11 Feb 2025 (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.
The objective of this observational study was to understand the effect of HBO on patients with SSNHL and its association with coagulation function and prognosis.
The main question it aims to answer is whether HBO therapy can improve outcomes and coagulation function in patients with SSNHL.
The prognosis of SSNHL patients receiving HBO and SSNHL patients not receiving HBO were compared
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From January 2022 to September 2024, in Putuo Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Otolaryngology Hospital Affiliated to Fudan University, Xinhua Hospital affiliated to Shanghai Jiao Tong University or Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, treating patients with sudden sensorineural deafness.
Key inclusion criteria (3 listed)
- Meet the diagnostic criteria for sudden deafness in the American Academy of Otolaryngology Head and Neck Surgery 2019 Clinical Practice Guidelines for Sudden Deafness;
- Aged 18-75 years old;
- Patients with unilateral sudden deafness for the first time, and the onset time is less than 2 weeks.
Key exclusion criteria (5 listed)
- Patients with other ear diseases, such as auditory trauma, barotrauma, retrocochlear disease, bilateral hearing loss, history of chronic otitis media in the same ear, and history of surgery in the same ear;
- Patients with serious primary diseases such as heart, liver, kidney dysfunction and hematopoietic system diseases;
- Pregnant and nursing patients;
- Accompanied by serious mental illness;
- Patients with incomplete clinical data.
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 |
|---|---|---|
| Hyperbaric oxygen treatmentHBO therapy is the process of inhaling 100% pure oxygen in an environment above one atmosphere (pressure range: 2.0-3.0 absolute atmospheres) to treat a disease. | Other | – |
Primary outcome
Hearing recovery rate
Time frame: From onset to 3 months after treatment
The rate of hearing recovery in patients with all levels of hearing loss at completion of treatment and at 3 months after termination of treatment was assessed according to the WHO Hearing Loss Rating Criteria 2021 to determine the success of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Sensorineural Hearing Loss (SSNHL) and Hyperbaric Oxygen Therapy, run by Sun Yuting at 1 site in China.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 14 May 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sun Yuting (+89 198 2175 8594, syt_354@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing recovery rate (time frame: From onset to 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2025.