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Study protocol
Vestibular prognosis in idiopathic sudden sensorineural hearing loss with vestibular dysfunction treated with oral or intratympanic glucocorticoids: a protocol for randomized controlled trial
Huawei Li
Fudan University Eye Ear Nose and Throat Hospital
Corresponding Author
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background
Idiopathic sudden sensorineural hearing loss (ISSNHL) is a rapid-onset sensorineural hearing impairment with unclear etiology and unsatisfying treatment effects. Vestibular dysfunction has been considered as a poor indicator in the clinical manifestations and prognosis of ISSNHL, which occurred in approximately 28%-57% cases. Glucocorticoids, administered through oral or intratympanic way, is currently a regular and standard treatment for ISSNHL based on hearing outcome. However, little investigations have been conducted on the recovery process and treatment effects of glucocorticoids on vestibular dysfunctions of ISSNHL. This study aims to compare the efficacy of oral or intratympanic glucocorticoids in ISSNHL with vestibular dysfunction in terms of the pattern and trajectory of possible process of vestibular function recovery.
Methods/Design
A randomized, outcome-assessor- and analyst-blinded, controlled, clinical trial (RCT) will be carried out. A group of seventy-two patients with ISSNHL complaining of vestibular dysfunction appearing as vertigo, dizziness or imbalance will be recruited and randomized into two arms of either oral or intratympanic glucocorticoids therapy with a 1:1 allocation ratio. The primary outcomes will be vestibular function outcomes assessed by sensory organization test, caloric test, video head impulse test, and vestibular evoked myogenic potentials; the secondary outcomes include self-reported vestibular dysfunction symptoms; dizziness-related handicap, visual analogue scale for vertigo and tinnitus; and pure tone audiometry. Assessment will be performed at baseline and at 1, 2, 4, and 8 weeks post-randomization. To our knowledge, this will be the first randomized controlled trial focusing on the prognosis of vestibular dysfunction in ISSNHL and the efficacy of glucocorticoids therapy for the vestibular dysfunction in this disease.
Discussion
This trial will be the first RCT study focusing on the progress and prognosis of vestibular dysfunction in ISSNHL. Efficacy of two commonly used therapies of glucocorticoids will be compared in both auditory and vestibular function fields, rather than in the hearing outcome alone.
Trial registration
ClinicalTrials.gov, NCT03974867. Registered on July 23, 2019.
Keywords
Vestibular function, sudden hearing loss, glucocorticoids
Figure 1
Table 1. Glucocorticoids therapy protocol in each group
|
|
Drug |
Protocol |
|
Group 1 |
Pred. |
Glucocorticoids therapy: d1-d7: Oral Pred. 1mg/kg/d (maximum daily dosage is no more than 60mg); d8-d9: Oral Pred. 10mg less than d7; d10-d11: Oral Pred. 10mg less than d9; d12: Oral Pred. 10mg less than d11; d13: Oral Pred. 10mg less than d12; d14: Oral Pred. 10mg less than d13;* |
|
Group 2 |
Met. |
Glucocorticoids therapy: One intratympanic injection of 40mg/ml Met. at d1, d3, d5, d7, d9, d11 and d13;** |
*If the patient’s weight is less than 50kg, the administration will be stopped after the day with < 10mg prednisone administered, for example, a patient weighs 45kg will stop receiving glucocorticoids at the 13th day;
**One day early or late of injection is allowed for practicality.
Pred., prednisone; Met., methylprednisolone; d=day;
Table 2. Difference in Vestibular Function Tests between Compensation of Central Vestibular System and Restoration of Peripheral Vestibular System
|
|
Compensation of CVS |
Restoration of PVS |
|
Subjective Complaints |
Normal |
Normal |
|
SOT |
Abnormal |
Normal |
|
Caloric test |
Static compensation: UW+ DP+ Dynamic compensation: UW+ DP- |
UW- DP- |
|
vHIT |
Abnormal |
Normal |
|
cVEMP/oVEMP |
Abnormal |
Normal |
CVS: central vestibular system; PVS: peripheral vestibular system; UW: unilateral weakness; DP: directional preponderance; SpN: spontaneous nystagmus
Table 3. Due to technical limitations, Table 3 is provided in the Supplementary Files section.
This is a list of supplementary files associated with this preprint. Click to download.
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CURRENT STATUS: Published
Version 1
Posted 07 Jan, 2020
Published
On 22 Jul, 2020
No community comments so far
Editorial decision: Minor revision
On 20 Mar, 2020
Review #2 received
Received 24 Feb, 2020
Reviewer #2 agreed
On 17 Feb, 2020
Review #1 received
Received 04 Feb, 2020
Reviewers invited
Invitations sent on 23 Jan, 2020
Reviewer #1 agreed
On 23 Jan, 2020
Editor assigned
On 21 Jan, 2020
Submission checks complete
On 04 Jan, 2020
First submitted
On 18 Dec, 2019
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Vestibular prognosis in idiopathic sudden sensorineural hearing loss with vestibular dysfunction treated with oral or intratympanic glucocorticoids: a protocol for randomized controlled trial
Huawei Li
Fudan University Eye Ear Nose and Throat Hospital
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 1
Posted 07 Jan, 2020
Published
On 22 Jul, 2020
No community comments so far
Editorial decision: Minor revision
On 20 Mar, 2020
Review #2 received
Received 24 Feb, 2020
Reviewer #2 agreed
On 17 Feb, 2020
Review #1 received
Received 04 Feb, 2020
Reviewers invited
Invitations sent on 23 Jan, 2020
Reviewer #1 agreed
On 23 Jan, 2020
Editor assigned
On 21 Jan, 2020
Submission checks complete
On 04 Jan, 2020
First submitted
On 18 Dec, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background
Idiopathic sudden sensorineural hearing loss (ISSNHL) is a rapid-onset sensorineural hearing impairment with unclear etiology and unsatisfying treatment effects. Vestibular dysfunction has been considered as a poor indicator in the clinical manifestations and prognosis of ISSNHL, which occurred in approximately 28%-57% cases. Glucocorticoids, administered through oral or intratympanic way, is currently a regular and standard treatment for ISSNHL based on hearing outcome. However, little investigations have been conducted on the recovery process and treatment effects of glucocorticoids on vestibular dysfunctions of ISSNHL. This study aims to compare the efficacy of oral or intratympanic glucocorticoids in ISSNHL with vestibular dysfunction in terms of the pattern and trajectory of possible process of vestibular function recovery.
Methods/Design
A randomized, outcome-assessor- and analyst-blinded, controlled, clinical trial (RCT) will be carried out. A group of seventy-two patients with ISSNHL complaining of vestibular dysfunction appearing as vertigo, dizziness or imbalance will be recruited and randomized into two arms of either oral or intratympanic glucocorticoids therapy with a 1:1 allocation ratio. The primary outcomes will be vestibular function outcomes assessed by sensory organization test, caloric test, video head impulse test, and vestibular evoked myogenic potentials; the secondary outcomes include self-reported vestibular dysfunction symptoms; dizziness-related handicap, visual analogue scale for vertigo and tinnitus; and pure tone audiometry. Assessment will be performed at baseline and at 1, 2, 4, and 8 weeks post-randomization. To our knowledge, this will be the first randomized controlled trial focusing on the prognosis of vestibular dysfunction in ISSNHL and the efficacy of glucocorticoids therapy for the vestibular dysfunction in this disease.
Discussion
This trial will be the first RCT study focusing on the progress and prognosis of vestibular dysfunction in ISSNHL. Efficacy of two commonly used therapies of glucocorticoids will be compared in both auditory and vestibular function fields, rather than in the hearing outcome alone.
Trial registration
ClinicalTrials.gov, NCT03974867. Registered on July 23, 2019.
Figure 1
Table 1. Glucocorticoids therapy protocol in each group
|
|
Drug |
Protocol |
|
Group 1 |
Pred. |
Glucocorticoids therapy: d1-d7: Oral Pred. 1mg/kg/d (maximum daily dosage is no more than 60mg); d8-d9: Oral Pred. 10mg less than d7; d10-d11: Oral Pred. 10mg less than d9; d12: Oral Pred. 10mg less than d11; d13: Oral Pred. 10mg less than d12; d14: Oral Pred. 10mg less than d13;* |
|
Group 2 |
Met. |
Glucocorticoids therapy: One intratympanic injection of 40mg/ml Met. at d1, d3, d5, d7, d9, d11 and d13;** |
*If the patient’s weight is less than 50kg, the administration will be stopped after the day with < 10mg prednisone administered, for example, a patient weighs 45kg will stop receiving glucocorticoids at the 13th day;
**One day early or late of injection is allowed for practicality.
Pred., prednisone; Met., methylprednisolone; d=day;
Table 2. Difference in Vestibular Function Tests between Compensation of Central Vestibular System and Restoration of Peripheral Vestibular System
|
|
Compensation of CVS |
Restoration of PVS |
|
Subjective Complaints |
Normal |
Normal |
|
SOT |
Abnormal |
Normal |
|
Caloric test |
Static compensation: UW+ DP+ Dynamic compensation: UW+ DP- |
UW- DP- |
|
vHIT |
Abnormal |
Normal |
|
cVEMP/oVEMP |
Abnormal |
Normal |
CVS: central vestibular system; PVS: peripheral vestibular system; UW: unilateral weakness; DP: directional preponderance; SpN: spontaneous nystagmus
Table 3. Due to technical limitations, Table 3 is provided in the Supplementary Files section.