Vestibular DisorderNCT03951584
Prognosis of Vestibular Dysfunction in Patients With Idiopathic Sudden Sensorineural Hearing Loss
An observational study of Vestibular Disorder and Sudden Hearing Loss, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
Idiopathic sudden sensorineural hearing loss (ISSNHL) refers to idiopathic sensorineural hearing loss of at least 30 dB over at least three test frequencies occurring over a 72-hour period. Vertigo has been considered a risk factor of poor prognosis in patients with ISSNHL. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Vestibular Disorder, Sudden Hearing Loss
- What is being tested?
- ISSNHL with vertigo
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2019to 1 May 2022
- Phase
- Observational
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who suffered from ISSNHL with vertigo and the onset of this disease was within 30 days, will be included in this study cohort. The enrollment of the participants will be held in the clinic of Eye and ENT Hospital of Fudan University.
Who may be able to join
- 16 to 70 years old.
- Diagnosed as ISSNHL.
- Present with vertigo.
- At least 1 abnormal result in vestibular function tests(SOT, vHIT, caloric reflex test, and VEMP).
- The onset of the disease was within 30 days.
Who cannot join
- Unwilling to sign informed consent.
- The cause of sudden hearing loss has been identified, such as trauma, vasogenic disease, et al.
- Bilateral hearing loss.
- Patients with coexisting vestibular disorders, including Meniere disease, vestibular neuritis, labyrinthitis, and peripheral vestibular loss et al.
- Patients not suitable to receiving vestibular function tests, such as those with severe cervical spine disease, cardiovascular disease, or pregnancy et al.
- Cognitive impairment;
- Other conditions that the investigator evaluated the patients as not appropriate for this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
Shanghai, Shanghai Municipality, 200031
About this study
Idiopathic sudden sensorineural hearing loss (ISSNHL) refers to idiopathic sensorineural hearing loss of at least 30 dB over at least three test frequencies occurring over a 72-hour period. Vertigo has been considered a risk factor of poor prognosis in patients with ISSNHL. However, the clinical outcome and development of vestibular function in these patients have not been reported yet. We'd like to conduct a study on the problem whether these patients resulted in a complete recovery of the peripheral vestibular functions or compensation of the central vestibular system. If the answer is the former one, these cases might be supportive evidence of regeneration of hair cells in vestibular disorders.
Read the detailed description
This study is designed as a prospective cohort study with only one cohort. Enrolment and data collection are performed by trained research staff who are not involved in the care of the patients. The primary measurement is the vestibular function tests including SOT, the caloric reflex test, vHIT, VEMP (cVEMP and oVEMP). The secondary measurements included PTA, DHI, and VAS. The sample size was set at 60 patients. The continuous variables were expressed as means ± standard deviation (SD) whereas categorical variables were expressed as frequency and percentage for data description. P <0.05 was considered statistically significant.
- Conditions
- Vestibular Disorder, Sudden Hearing Loss
- Being tested
- ISSNHL with vertigo
- Keywords
- idiopathic sudden sensorineural hearing loss, vestibular dysfunction
- Medical subject headings
- Vestibular Diseases, Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISSNHL with vertigoOther
Participants who suffered from ISSNHL with vertigo will be included in this study. Participants will undergo vestibular function tests including caloric test, sensory organization test, video head impulse test and vestibular evoked myogenic potentials at baseline and 2 months after onset as primary outcome, to evaluate the damage and prognosis of vestibular function.
| Study group | Role | What they receive |
|---|---|---|
| ISSNHL with vertigo | Participants who suffered from ISSNHL with vertigo will be included in this study cohort. Participants will undergo vestibular function tests including caloric test, sensory organization test, video head impulse test and vestibular evoked myogenic potentials at baseline and 2 months after onset, to evaluate the damage and prognosis of vestibular function. Receives: Other: ISSNHL with vertigo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal rate of vestibular function in the Sensory Organization Test(SOT) at baseline.
abnormal rate=(number of participants who have abnormal results in vestibular function in SOT at the baseline)/(number of participants in total)
Measured: Baseline
Recovery rate of vestibular input in the Sensory Organization Test(SOT) at 2-months follow-up after onset.
recovery rate=(number of participants who had abnormal results in vestibular function in SOT at the baseline and get normal vestibular function results in SOT at 2-months follow-up after onset)/(number of participants who had abnormal vestibular function results in SOT at the baseline)
Measured: 2 months after onset
Abnormal rate of the caloric test at baseline.
Abnormal rate=(number of participants who have abnormal results in the caloric test at the baseline)/(number of participants in total).
An abnormal result is considered if unilateral reaction weakening is greater than 22%, and/or directional preponderance is greater than 27%.
Measured: Baseline
Recovery rate of the caloric test at 2-months follow-up after onset.
recovery rate=(number of participants who had abnormal results in the caloric test at the baseline and get normal results in the caloric test at 2-months follow-up after onset)/(number of participants who get abnormal results in the caloric test at the baseline).
An abnormal result is considered if unilateral reaction weakening is greater than 22%, and/or directional preponderance is greater than 27%.
Measured: 2 months after onset
Abnormal rate of the vHIT at baseline.
Abnormal rate=(number of participants who have abnormal results in vHIT at the baseline)/(number of participants in total).
An abnormal result is considered if there are pathological saccades and the gain of each semicircular canal is out of normal range.
Measured: Baseline
Recovery rate of the vHIT at 2-months follow-up after onset.
recovery rate=(number of the participants who had abnormal results in vHIT at the baseline and get normal results in vHIT at 2-months follow-up after onset)/(number of the participants who get abnormal results in vHIT at the baseline).
An abnormal result is considered if there are pathological saccades and the gain of each semicircular canal is out of normal range.
Measured: 2 months after onset
Abnormal rate of Cervical Vestibular Evoked Myogenic Potentials (cVEMP) at baseline.
Abnormal rate=(number of participants who have abnormal results in cVEMP at the baseline)/(number of participants in total) The abnormal result is considered if potentials were not elicited or out of normal range, or the asymmetrical ratio is larger than normal.
Measured: Baseline
Recovery rate of Cervical Vestibular Evoked Myogenic Potentials (cVEMP) at 2-months follow-up after onset.
recovery rate=(number of the participants who had abnormal results in cVEMP at the baseline and get normal results in cVEMP at 2-months follow-up after onset)/(number of the participants who had abnormal results in cVEMP at the baseline) The abnormal result is considered if potentials were not elicited or out of normal range, or the asymmetrical ratio is larger than normal.
Measured: 2 months after onset
Abnormal rate of Ocular Vestibular Evoked Myogenic Potentials (oVEMP) at baseline.
Abnormal rate=(number of participants who had abnormal results in oVEMP at the baseline)/(number of participants in total) The abnormal result is considered if potentials were not elicited or out of normal range, or the asymmetrical ratio is larger than normal.
Measured: Baseline
Recovery rate of Ocular Vestibular Evoked Myogenic Potentials (oVEMP) at 2-months follow-up after onset.
recovery rate=(number of the participants who had abnormal results in oVEMP at the baseline and get normal results in oVEMP at 2-months follow-up after onset)/(number of the participants who had abnormal results in oVEMP at the baseline) The abnormal result is considered if potentials were not elicited or out of normal range, or the asymmetrical ratio is larger than normal.
Measured: 2 months after onset
Secondary outcomes (3)
Change of Dizziness Handicap Inventory at 2 months after onset
Mean value of change of DHI from baseline at 2 months after onset in each participant.
Subjective evaluation of vertigo by participants. Score range from 0 to 100 (0 refers to no influence on daily life, while 100 refers to the most severe influence on patient's daily life.)
Measured: 2 months after onset
Change of Visual Analogue Scale in Vertigo at 2 month after onset
Mean value of change of VAS-V from baseline at 2 months after onset in each participant.
Subjective evaluation of vertigo by participants. Score from 0 to 10. The larger the score, the more severe the vertigo is.
Measured: 2 months after onset
Change of Pure Tone Audiometry(PTA) at 2 months after onset
mean value of change of PTA in each participant at 2 months after onset from baseline (if the participants can provide with an earlier PTA result before enrollment and after onset, which we believe is of high possibility, this PTA result will be considered as baseline parameters).
Measured: 2 months after onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start15 May 2019
- Primary completion1 May 2022
- Study completion1 May 2022
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 Vestibular DisorderStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huawei Li, Phd & MD, Study chair, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951584
- Sponsor's protocol ID
- Cohort ISSNHL with vertigo
- Status last verified
- Feb 2020
- First submitted
- 6 May 2019
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: For IPD please contact the author at haoweiming1993@163.com
Publications
Stachler RJ, Chandrasekhar SS, Archer SM, Rosenfeld RM, Schwartz SR, Barrs DM, Brown SR, Fife TD, Ford P, Ganiats TG, Hollingsworth DB, Lewandowski CA, Montano JJ, Saunders JE, Tucci DL, Valente M, Warren BE, Yaremchuk KL, Robertson PJ; American Academy of Otolaryngology-Head and Neck Surgery. Clinical practice guideline: sudden hearing loss. Otolaryngol Head Neck Surg. 2012 Mar;146(3 Suppl):S1-35. doi: 10.1177/0194599812436449.
PubMed 22383545Wen YH, Chen PR, Wu HP. Prognostic factors of profound idiopathic sudden sensorineural hearing loss. Eur Arch Otorhinolaryngol. 2014 Jun;271(6):1423-9. doi: 10.1007/s00405-013-2593-y. Epub 2013 Jun 15.
PubMed 23771280Yu H, Li H. Association of Vertigo With Hearing Outcomes in Patients With Sudden Sensorineural Hearing Loss: A Systematic Review and Meta-analysis. JAMA Otolaryngol Head Neck Surg. 2018 Aug 1;144(8):677-683. doi: 10.1001/jamaoto.2018.0648.
PubMed 29931169Rauch SD. Clinical practice. Idiopathic sudden sensorineural hearing loss. N Engl J Med. 2008 Aug 21;359(8):833-40. doi: 10.1056/NEJMcp0802129. No abstract available.
PubMed 18716300Hao W, Ye L, Yu H, Li H. Prognosis of vestibular dysfunction in idiopathic sudden sensorineural hearing loss with vertigo: a prospective cohort study. J Neurol. 2023 Nov;270(11):5516-5526. doi: 10.1007/s00415-023-11894-w. Epub 2023 Jul 30.
PubMed 37517037
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis of Vestibular Dysfunction in Patients With Idiopathic Sudden Sensorineural Hearing Loss
- ClinicalTrials.gov ID
- NCT03951584
- Acronym / sponsor ID
- Cohort ISSNHL with vertigo
- Conditions
- Vestibular Disorder, Sudden Hearing Loss
- Keywords
- idiopathic sudden sensorineural hearing loss, vestibular dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 15 May 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.
Idiopathic sudden sensorineural hearing loss (ISSNHL) refers to idiopathic sensorineural hearing loss of at least 30 dB over at least three test frequencies occurring over a 72-hour period. Vertigo has been considered a risk factor of poor prognosis in patients with ISSNHL. However, the clinical outcome and development of vestibular function in these patients have not been reported yet. We'd like to conduct a study on the problem whether these patients resulted in a complete recovery of the peripheral vestibular functions or compensation of the central vestibular system. If the answer is the former one, these cases might be supportive evidence of regeneration of hair cells in vestibular disorders.
Detailed description
This study is designed as a prospective cohort study with only one cohort. Enrolment and data collection are performed by trained research staff who are not involved in the care of the patients. The primary measurement is the vestibular function tests including SOT, the caloric reflex test, vHIT, VEMP (cVEMP and oVEMP). The secondary measurements included PTA, DHI, and VAS. The sample size was set at 60 patients. The continuous variables were expressed as means ± standard deviation (SD) whereas categorical variables were expressed as frequency and percentage for data description. P <0.05 was considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ISSNHL with vertigo | – | Other: ISSNHL with vertigoParticipants who suffered from ISSNHL with vertigo will be included in this study cohort. Participants will undergo vestibular function tests including caloric test, sensory organization test, video head impulse test and vestibular evoked myogenic potentials at baseline and 2 months after onset, to evaluate the damage and prognosis of vestibular function. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who suffered from ISSNHL with vertigo and the onset of this disease was within 30 days, will be included in this study cohort. The enrollment of the participants will be held in the clinic of Eye and ENT Hospital of Fudan University.
Key inclusion criteria (5 listed)
- 16 to 70 years old.
- Diagnosed as ISSNHL.
- Present with vertigo.
- At least 1 abnormal result in vestibular function tests(SOT, vHIT, caloric reflex test, and VEMP).
- The onset of the disease was within 30 days.
Key exclusion criteria (7 listed)
- Unwilling to sign informed consent.
- The cause of sudden hearing loss has been identified, such as trauma, vasogenic disease, et al.
- Bilateral hearing loss.
- Patients with coexisting vestibular disorders, including Meniere disease, vestibular neuritis, labyrinthitis, and peripheral vestibular loss et al.
- Patients not suitable to receiving vestibular function tests, such as those with severe cervical spine disease, cardiovascular disease, or pregnancy et al.
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 |
|---|---|---|
| ISSNHL with vertigoParticipants who suffered from ISSNHL with vertigo will be included in this study. Participants will undergo vestibular function tests including caloric test, sensory organization test, video head impulse test and vestibular evoked myogenic potentials at baseline and 2 months after onset as primary outcome, to evaluate the damage and prognosis of vestibular function. | Other | ISSNHL with vertigo |
Primary outcome
Abnormal rate of vestibular function in the Sensory Organization Test(SOT) at baseline.
Time frame: Baseline
abnormal rate=(number of participants who have abnormal results in vestibular function in SOT at the baseline)/(number of participants in total)
Recovery rate of vestibular input in the Sensory Organization Test(SOT) at 2-months follow-up after onset.
Time frame: 2 months after onset
recovery rate=(number of participants who had abnormal results in vestibular function in SOT at the baseline and get normal vestibular function results in SOT at 2-months follow-up after onset)/(number of participants who had abnormal vestibular function results in SOT at the baseline)
Abnormal rate of the caloric test at baseline.
Time frame: Baseline
Abnormal rate=(number of participants who have abnormal results in the caloric test at the baseline)/(number of participants in total). An abnormal result is considered if unilateral reaction weakening is greater than 22%, and/or directional preponderance is greater than 27%.
Recovery rate of the caloric test at 2-months follow-up after onset.
Time frame: 2 months after onset
recovery rate=(number of participants who had abnormal results in the caloric test at the baseline and get normal results in the caloric test at 2-months follow-up after onset)/(number of participants who get abnormal results in the caloric test at the baseline). An abnormal result is considered if unilateral reaction weakening is greater than 22%, and/or directional preponderance is greater than 27%.
Abnormal rate of the vHIT at baseline.
Time frame: Baseline
Abnormal rate=(number of participants who have abnormal results in vHIT at the baseline)/(number of participants in total). An abnormal result is considered if there are pathological saccades and the gain of each semicircular canal is out of normal range.
Recovery rate of the vHIT at 2-months follow-up after onset.
Time frame: 2 months after onset
recovery rate=(number of the participants who had abnormal results in vHIT at the baseline and get normal results in vHIT at 2-months follow-up after onset)/(number of the participants who get abnormal results in vHIT at the baseline). An abnormal result is considered if there are pathological saccades and the gain of each semicircular canal is out of normal range.
Abnormal rate of Cervical Vestibular Evoked Myogenic Potentials (cVEMP) at baseline.
Time frame: Baseline
Abnormal rate=(number of participants who have abnormal results in cVEMP at the baseline)/(number of participants in total) The abnormal result is considered if potentials were not elicited or out of normal range, or the asymmetrical ratio is larger than normal.
Recovery rate of Cervical Vestibular Evoked Myogenic Potentials (cVEMP) at 2-months follow-up after onset.
Time frame: 2 months after onset
recovery rate=(number of the participants who had abnormal results in cVEMP at the baseline and get normal results in cVEMP at 2-months follow-up after onset)/(number of the participants who had abnormal results in cVEMP at the baseline) The abnormal result is considered if potentials were not elicited or out of normal range, or the asymmetrical ratio is larger than normal.
Abnormal rate of Ocular Vestibular Evoked Myogenic Potentials (oVEMP) at baseline.
Time frame: Baseline
Abnormal rate=(number of participants who had abnormal results in oVEMP at the baseline)/(number of participants in total) The abnormal result is considered if potentials were not elicited or out of normal range, or the asymmetrical ratio is larger than normal.
Recovery rate of Ocular Vestibular Evoked Myogenic Potentials (oVEMP) at 2-months follow-up after onset.
Time frame: 2 months after onset
recovery rate=(number of the participants who had abnormal results in oVEMP at the baseline and get normal results in oVEMP at 2-months follow-up after onset)/(number of the participants who had abnormal results in oVEMP at the baseline) The abnormal result is considered if potentials were not elicited or out of normal range, or the asymmetrical ratio is larger than normal.
3 secondary outcomes
Change of Dizziness Handicap Inventory at 2 months after onset
Time frame: 2 months after onset
Change of Visual Analogue Scale in Vertigo at 2 month after onset
Time frame: 2 months after onset
Change of Pure Tone Audiometry(PTA) at 2 months after onset
Time frame: 2 months after onset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Background: PubMed 22383545Stachler RJ, Chandrasekhar SS, Archer SM, Rosenfeld RM, Schwartz SR, Barrs DM, Brown SR, Fife TD, Ford P, Ganiats TG, Hollingsworth DB, Lewandowski CA, Montano JJ, Saunders JE, Tucci DL, Valente M, Warren BE, Yaremchuk KL, Robertson PJ; American Academy of Otolaryngology-Head and Neck Surgery. Clinical practice guideline: sudden hearing loss. Otolaryngol Head Neck Surg. 2012 Mar;146(3 Suppl):S1-35. doi: 10.1177/0194599812436449.
- Background: PubMed 23771280Wen YH, Chen PR, Wu HP. Prognostic factors of profound idiopathic sudden sensorineural hearing loss. Eur Arch Otorhinolaryngol. 2014 Jun;271(6):1423-9. doi: 10.1007/s00405-013-2593-y. Epub 2013 Jun 15.
- Background: PubMed 29931169Yu H, Li H. Association of Vertigo With Hearing Outcomes in Patients With Sudden Sensorineural Hearing Loss: A Systematic Review and Meta-analysis. JAMA Otolaryngol Head Neck Surg. 2018 Aug 1;144(8):677-683. doi: 10.1001/jamaoto.2018.0648.
- Background: PubMed 18716300Rauch SD. Clinical practice. Idiopathic sudden sensorineural hearing loss. N Engl J Med. 2008 Aug 21;359(8):833-40. doi: 10.1056/NEJMcp0802129. No abstract available.
- Derived from this study: PubMed 37517037Hao W, Ye L, Yu H, Li H. Prognosis of vestibular dysfunction in idiopathic sudden sensorineural hearing loss with vertigo: a prospective cohort study. J Neurol. 2023 Nov;270(11):5516-5526. doi: 10.1007/s00415-023-11894-w. Epub 2023 Jul 30.
- Individual participant dataSharing planned: Yes. For IPD please contact the author at haoweiming1993@163.com
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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.
Huawei Li, Phd & MD study chair
Eye & ENT Hospital of Fudan University
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 Vestibular Disorder and Sudden Hearing Loss, run by Eye & ENT Hospital of Fudan University 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 4 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abnormal rate of vestibular function in the Sensory Organization Test(SOT) at baseline. (time frame: Baseline). The study lists 10 primary outcomes in all. 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 NCT03951584, 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 4 Nov 2022.