Sudden Loss of HearingPhase 2/3NCT00416143
Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss
A Phase 2/3 study testing bed rest and prednisone - oral corticosteroid 1mg/kg/D for 1 week in people with Sudden Loss of Hearing, run by Sheba Medical Center at 1 site in Israel.
Trial summary
sudden sensorineural hearing loss: idiopathic in most cases 5-20/100,000 new cases annually in the U.S no establishes pathogenesis treated with oral steroids in most cases ~50% improvement in hearing levels bed rest - acceptable treatment, not well investigated Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Sudden Loss of Hearing
- What is being tested?
- bed rest and prednisone - oral corticosteroid 1mg/kg/D for 1 week
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2006to Dec 2008
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with sudden sensorineural hearing loss
Who cannot join
- age less than 16 years
- contraindication for oral steroid treatment
- prior steroid treatment for hearing loss
- pregnent women
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Tel HaShomer
Eldar Carmel, MD, 972-3-5302442, eldarca@sheba.health.gov.il
Eldar Carmel, MD
About this study
sudden sensorineural hearing loss:
- idiopathic in most cases
- 5-20/100,000 new cases annually in the U.S
- no establishes pathogenesis
- treated with oral steroids in most cases
- ~50% improvement in hearing levels
- bed rest - acceptable treatment, not well investigated
- Conditions
- Sudden Loss of Hearing
- Being tested
- bed rest, prednisone - oral corticosteroid 1mg/kg/D for 1 week
- Keywords
- Bed rest for idiopathic sudden sensorineural hearing loss
- 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.
bed restProcedure or surgery
prednisone - oral corticosteroid 1mg/kg/D for 1 weekDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
hearing improvement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2006 (estimated)
- Study startJun 2006
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Loss of HearingStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Eldar Carmel, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416143
- Sponsor's protocol ID
- SHEBA-06-4065-EC-CTIL
- Status last verified
- Dec 2006
- First submitted
- 24 Dec 2006
- Last updated
- 27 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss
- ClinicalTrials.gov ID
- NCT00416143
- Acronym / sponsor ID
- SHEBA-06-4065-EC-CTIL
- Conditions
- Sudden Loss of Hearing
- Keywords
- Bed rest for idiopathic sudden sensorineural hearing loss
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jun 2006
- Study completion
- Dec 2008
- First posted
- 27 Dec 2006 (estimated)
- 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.
sudden sensorineural hearing loss:
- idiopathic in most cases
- 5-20/100,000 new cases annually in the U.S
- no establishes pathogenesis
- treated with oral steroids in most cases
- ~50% improvement in hearing levels
- bed rest - acceptable treatment, not well investigated
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with sudden sensorineural hearing loss
Key exclusion criteria (4 listed)
- age less than 16 years
- contraindication for oral steroid treatment
- prior steroid treatment for hearing loss
- pregnent women
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 |
|---|---|---|
| bed rest | Procedure or surgery | – |
| prednisone - oral corticosteroid 1mg/kg/D for 1 week | Drug | – |
Primary outcome
hearing improvement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2006.
Related trials for Sudden Loss of Hearing
RecruitingPhase 2
Efficacy and Safety of Hydroxychloroquine in the Treatment of Sudden Sensorineural Hearing Loss
Sudden Hearing Loss
Not yet recruitingPhase 3
Autologous Circulating Extracellular Vesicles for Total-Type Sudden Sensorineural Hearing Loss
Sudden Sensorineural Hearing Loss (SSNHL)
Not yet recruitingPhase 2
Efficacy and Safety of Intracochlear Injection of Glucocorticoid Through the Round Window Membrane in Patients With Profound or Complete Sudden Sensorineural Hearing Loss
Sudden Hearing Loss
RecruitingPhase 4
Comparison of the Effectiveness of Oral and Intratympanic Corticosteroid Treatments in Patients Diagnosed With Sudden Sensorineural Hearing Loss
Sudden Sensorineural Hearing Loss
Not yet recruiting
CGM-guided Patch Pump vs Basal-Bolus Injection for Steroid-Induced Hyperglycemia in Sudden Sensorineural Hearing Loss: SHIP Trial
Sudden Sensorineural Hearing Loss (SSNHL), Prediabetes / Type 2 Diabetes
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.
Eldar Carmel, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing bed rest and prednisone - oral corticosteroid 1mg/kg/D for 1 week in people with Sudden Loss of Hearing, run by Sheba Medical Center at 1 site in Israel.
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 1 inclusion and 4 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 27 Dec 2006. 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 Israel. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Eldar Carmel, MD (972-3-5302442, eldarca@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hearing improvement. 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 27 Dec 2006.