Vestibular DisorderNCT03431506
Vestibular Function and Vestibular Rehabilitation in SSHL With Vertigo
A study testing Vestibular rehabilitation in people with Vestibular Disorder, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
To evaluate the vestibular function and vestibular rehabilitation in sudden sensorneural hearing loss(SSHL) with vertigo Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Vestibular Disorder
- What is being tested?
- Vestibular rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 30 Dec 2019
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A rapid onset sensorineural hearing loss of more than 30 dB for at least three contiguous audiometric frequencies within a period of 3 days, according to standard AAO - HNS;
- Within 10 days from onset;
- Without other virus infectious disease within three months.
Who cannot join
- BPPV; Meniere's disease and vestibular migraine.
- With certain Known etiology, including acoustic neuroma, heart cerebrovascular accident, injury, Hunt syndrome, etc
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
Shanghai, Shanghai Municipality, 200031
Huawei Li, Phd &MD, huaweili2000@shmu.edu.cn
Huawei Li, Phd &MD, huaweili2000@163.com
About this study
Official title: Vestibular Function and Vestibular Rehabilitation in Sudden Sensorneural Hearing Loss With Vertigo
To evaluate the vestibular function and vestibular rehabilitation in sudden sensorneural hearing loss(SSHL) with vertigo
Read the detailed description
Approximately 5-20 per 100,000 persons are afflicted with SSHL annually, and nearly 20-60% of SSHL patients complain of simultaneous vertigo.The aim of this study was to evaluate the prevalence of vestibulocochlear lesions in sudden sensorneural hearing loss(SSHL) with vertigo, as well as the role of vestibular rehabilitation in the prognosis of SSHL with vertigo.
- Conditions
- Vestibular Disorder
- Being tested
- Vestibular rehabilitation
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular rehabilitationBehavioural
Vestibular Rehabilitation Exercises
| Study group | Role | What they receive |
|---|---|---|
| non-training group | Active comparator | Not described Receives: Behavioral: Vestibular rehabilitation |
| training group | Experimental | Not described Receives: Behavioral: Vestibular rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 1(before treatment)
Vestibular function status in SSHL with vertigo at stage 1(before treatment)
Measured: before treatment
Secondary outcomes (2)
Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 2(2 weeks after treatment)
Vestibular function status in SSHL with vertigo at stage 2(2 weeks after treatment)
Measured: 2 weeks after treatment
Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 2(2 months after treatment)
Vestibular function status in SSHL with vertigo at stage 2(2 months after treatment)
Measured: 2 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 posted13 Feb 2018
- Study start1 Dec 2017
- Primary completion30 May 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431506
- Sponsor's protocol ID
- Vestibular function in SSHL
- Status last verified
- Feb 2018
- First submitted
- 16 Jan 2018
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Function and Vestibular Rehabilitation in Sudden Sensorneural Hearing Loss With Vertigo
- ClinicalTrials.gov ID
- NCT03431506
- Acronym / sponsor ID
- Vestibular function in SSHL
- Conditions
- Vestibular Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 May 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 13 Feb 2018 (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.
To evaluate the vestibular function and vestibular rehabilitation in sudden sensorneural hearing loss(SSHL) with vertigo
Detailed description
Approximately 5-20 per 100,000 persons are afflicted with SSHL annually, and nearly 20-60% of SSHL patients complain of simultaneous vertigo.The aim of this study was to evaluate the prevalence of vestibulocochlear lesions in sudden sensorneural hearing loss(SSHL) with vertigo, as well as the role of vestibular rehabilitation in the prognosis of SSHL with vertigo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-training group | Active comparator | Behavioral: Vestibular rehabilitation |
| training group | Experimental | Behavioral: Vestibular rehabilitation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- A rapid onset sensorineural hearing loss of more than 30 dB for at least three contiguous audiometric frequencies within a period of 3 days, according to standard AAO - HNS;
- Within 10 days from onset;
- Without other virus infectious disease within three months.
Key exclusion criteria (2 listed)
- BPPV; Meniere's disease and vestibular migraine.
- With certain Known etiology, including acoustic neuroma, heart cerebrovascular accident, injury, Hunt syndrome, etc
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 |
|---|---|---|
| Vestibular rehabilitationVestibular Rehabilitation Exercises | Behavioural | non-training group, training group |
Primary outcome
Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 1(before treatment)
Time frame: before treatment
Vestibular function status in SSHL with vertigo at stage 1(before treatment)
2 secondary outcomes
Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 2(2 weeks after treatment)
Time frame: 2 weeks after treatment
Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 2(2 months after treatment)
Time frame: 2 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular rehabilitation in people with Vestibular Disorder, 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 3 inclusion and 2 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 13 Feb 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huawei Li, Phd &MD (+86-13636423139, huaweili2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 1(before treatment) (time frame: before 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 13 Feb 2018.