Sudden Hearing LossPhase 4NCT04192656
The Effect of PAP on ISSHL Comorbided With OSA
A Phase 4 study testing non-invasive positive airway pressure, Methylprednisolone Hemisuccinate and Ginaton in people with Sudden Hearing Loss and Obstructive Sleep Apnea, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
This clinical randomized controlled study is to explore the effect of positive airway pressure(PAP) on patients in Beijing Tsinghua Changgung Hospital diagnosed with both idiopathic sudden sensorineural hearing loss comorbided(ISSHL) and obstructive sleep apnea(OSA) between Dec. 2019 to Dec. 2029. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sudden Hearing Loss, Obstructive Sleep Apnea
- What is being tested?
- non-invasive positive airway pressure, Methylprednisolone Hemisuccinate and Ginaton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to Dec 2029
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged >= 18 and <= 70,
- diagnosed with OSA by full-night in-lab or home-stay PSG according to AASM 2012 criteria, and AHI > 15/h,
- diagnosed with ISSHL by AAO-HNS 2019 criteria,
- ISSHL onset within 1 week.
Who cannot join
- sudden hearing loss with certain causes,
- with severe comorbid diseases,
- pregnant or breast-feeding women,
- AHI <= 15/h,
- hearing threshold recovered > 50% when included,
- previously regularly treated with PAP.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Haijin Yi, MD contact
China1 site, 1 recruiting
- Recruiting
Beijing Tsinhgua Changgung Hospital
Beijing, Beijing Municipality, 100028
Xin Cao, 86-15810519277, caoxin19860201@163.com
Mu He, 86-15210588954, muhe2009@qq.com
About this study
Official title: The Effect of Positive Airway Pressure on Idiopathic Sudden Sensorineural Hearing Loss Comorbided With Obstructive Sleep Apnea: A Clinical Randomized Controlled Study
This clinical randomized controlled study is to explore the effect of positive airway pressure(PAP) on patients in Beijing Tsinghua Changgung Hospital diagnosed with both idiopathic sudden sensorineural hearing loss comorbided(ISSHL) and obstructive sleep apnea(OSA) between Dec. 2019 to Dec. 2029.
- Conditions
- Sudden Hearing Loss, Obstructive Sleep Apnea
- Being tested
- non-invasive positive airway pressure, Methylprednisolone Hemisuccinate, Ginaton
- Medical subject headings
- Hearing Loss, Sudden, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive positive airway pressureDevice
non-invasive positive airway pressure is the first-line treatment for obstructive sleep apnea
Methylprednisolone HemisuccinateDrug
Also called Methylprednisolone, MP
Methylprednisolone is the first-line treatment of idiopathic sudden sensorineural hearing loss
GinatonDrug
Also called Ginkgo biloba extract,GBE
ginnaton is ginkgo biloba extract
| Study group | Role | What they receive |
|---|---|---|
| PAP plus medication | Experimental | patients treated by both PAP and medication Receives: Device: non-invasive positive airway pressure; Drug: Methylprednisolone Hemisuccinate; Drug: Ginaton |
| medication | Active comparator | patients treated by medication only Receives: Drug: Methylprednisolone Hemisuccinate; Drug: Ginaton |
What is being measured
The primary outcome is the main question the study is designed to answer.
hearing threshold
the recovery of hearing threshold which will be measured by pure tone audiometry
Measured: 3 months after onset of ISSHL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start1 Nov 2019
- Primary completionDec 2024 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Sudden Hearing LossStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ye Jingying, Beijing Tsinghua Chang Gung Hospital
- Investigators
- Juanjuan Gao, MD, Principal investigator, Beijing Tsinghua Changung Hospitaljingying Ye, MD, Study chair, Beijing Tsinghua Changung HospitalHaijin Yi, MD, Study director, Beijing Tsinghua Changung HospitalMu He, MD, Principal investigator, Beijing Tsinghua Changung HospitalXin Cao, MA, Principal investigator, Beijing Tsinghua Changung HospitalXingxing Lu, MA, Principal investigator, Beijing Tsinghua Changung HospitalSichao Liang, MA, Principal investigator, Beijing Tsinghua Changung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192656
- Sponsor's protocol ID
- BTCHENT201901
- Status last verified
- Dec 2019
- First submitted
- 9 Dec 2019
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hizli O, Ozcan M, Unal A. Evaluation of comorbidities in patients with OSAS and simple snoring. ScientificWorldJournal. 2013 Apr 18;2013:709292. doi: 10.1155/2013/709292. Print 2013.
PubMed 23710145Kayabasi S, Iriz A, Cayonu M, Cengiz B, Acar A, Boynuegri S, Mujdeci B, Eryilmaz A. Vestibular functions were found to be impaired in patients with moderate-to-severe obstructive sleep apnea. Laryngoscope. 2015 May;125(5):1244-8. doi: 10.1002/lary.25021. Epub 2014 Nov 12.
PubMed 25388224Casale M, Vesperini E, Potena M, Pappacena M, Bressi F, Baptista PJ, Salvinelli F. Is obstructive sleep apnea syndrome a risk factor for auditory pathway? Sleep Breath. 2012 Jun;16(2):413-7. doi: 10.1007/s11325-011-0517-x. Epub 2011 Apr 9.
PubMed 21479758Fu Q, Wang T, Liang Y, Lin Y, Zhao X, Wan J, Fan S. Auditory Deficits in Patients With Mild and Moderate Obstructive Sleep Apnea Syndrome: A Speech Syllable Evoked Auditory Brainstem Response Study. Clin Exp Otorhinolaryngol. 2019 Feb;12(1):58-65. doi: 10.21053/ceo.2018.00017. Epub 2018 Aug 24.
PubMed 30134647Sheu JJ, Wu CS, Lin HC. Association between obstructive sleep apnea and sudden sensorineural hearing loss: a population-based case-control study. Arch Otolaryngol Head Neck Surg. 2012 Jan;138(1):55-9. doi: 10.1001/archoto.2011.227.
PubMed 22249630
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Positive Airway Pressure on Idiopathic Sudden Sensorineural Hearing Loss Comorbided With Obstructive Sleep Apnea: A Clinical Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04192656
- Acronym / sponsor ID
- BTCHENT201901
- Conditions
- Sudden Hearing Loss, Obstructive Sleep Apnea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 10 Dec 2019 (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.
This clinical randomized controlled study is to explore the effect of positive airway pressure(PAP) on patients in Beijing Tsinghua Changgung Hospital diagnosed with both idiopathic sudden sensorineural hearing loss comorbided(ISSHL) and obstructive sleep apnea(OSA) between Dec. 2019 to Dec. 2029.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAP plus medication | Experimental | Device: non-invasive positive airway pressure, Drug: Methylprednisolone Hemisuccinate, Drug: Ginatonpatients treated by both PAP and medication |
| medication | Active comparator | Drug: Methylprednisolone Hemisuccinate, Drug: Ginatonpatients treated by medication only |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged >= 18 and <= 70,
- diagnosed with OSA by full-night in-lab or home-stay PSG according to AASM 2012 criteria, and AHI > 15/h,
- diagnosed with ISSHL by AAO-HNS 2019 criteria,
- ISSHL onset within 1 week.
Key exclusion criteria (6 listed)
- sudden hearing loss with certain causes,
- with severe comorbid diseases,
- pregnant or breast-feeding women,
- AHI <= 15/h,
- hearing threshold recovered > 50% when included,
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 |
|---|---|---|
| non-invasive positive airway pressurenon-invasive positive airway pressure is the first-line treatment for obstructive sleep apnea | Device | PAP plus medication |
| Methylprednisolone HemisuccinateAlso: Methylprednisolone, MPMethylprednisolone is the first-line treatment of idiopathic sudden sensorineural hearing loss | Drug | PAP plus medication, medication |
| GinatonAlso: Ginkgo biloba extract,GBEginnaton is ginkgo biloba extract | Drug | PAP plus medication, medication |
Primary outcome
hearing threshold
Time frame: 3 months after onset of ISSHL
the recovery of hearing threshold which will be measured by pure tone audiometry
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 10 Dec 2019.
- Background: PubMed 23710145Hizli O, Ozcan M, Unal A. Evaluation of comorbidities in patients with OSAS and simple snoring. ScientificWorldJournal. 2013 Apr 18;2013:709292. doi: 10.1155/2013/709292. Print 2013.
- Background: PubMed 25388224Kayabasi S, Iriz A, Cayonu M, Cengiz B, Acar A, Boynuegri S, Mujdeci B, Eryilmaz A. Vestibular functions were found to be impaired in patients with moderate-to-severe obstructive sleep apnea. Laryngoscope. 2015 May;125(5):1244-8. doi: 10.1002/lary.25021. Epub 2014 Nov 12.
- Background: PubMed 21479758Casale M, Vesperini E, Potena M, Pappacena M, Bressi F, Baptista PJ, Salvinelli F. Is obstructive sleep apnea syndrome a risk factor for auditory pathway? Sleep Breath. 2012 Jun;16(2):413-7. doi: 10.1007/s11325-011-0517-x. Epub 2011 Apr 9.
- Background: PubMed 30134647Fu Q, Wang T, Liang Y, Lin Y, Zhao X, Wan J, Fan S. Auditory Deficits in Patients With Mild and Moderate Obstructive Sleep Apnea Syndrome: A Speech Syllable Evoked Auditory Brainstem Response Study. Clin Exp Otorhinolaryngol. 2019 Feb;12(1):58-65. doi: 10.21053/ceo.2018.00017. Epub 2018 Aug 24.
- Background: PubMed 22249630Sheu JJ, Wu CS, Lin HC. Association between obstructive sleep apnea and sudden sensorineural hearing loss: a population-based case-control study. Arch Otolaryngol Head Neck Surg. 2012 Jan;138(1):55-9. doi: 10.1001/archoto.2011.227.
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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.
Haijin Yi, MD contact
Juanjuan Gao, MD principal investigator
Beijing Tsinghua Changung Hospital
jingying Ye, MD study chair
Beijing Tsinghua Changung Hospital
Haijin Yi, MD study director
Beijing Tsinghua Changung Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing non-invasive positive airway pressure, Methylprednisolone Hemisuccinate and Ginaton in people with Sudden Hearing Loss and Obstructive Sleep Apnea, run by Beijing Tsinghua Chang Gung Hospital 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Dec 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jingying Ye, MD (+86-13701396970, yejingying@163.vip.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hearing threshold (time frame: 3 months after onset of ISSHL). 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 NCT04192656, which also lists 5 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 10 Dec 2019.