Acute Otitis MediaNCT03315156
Taste Changes in Acute Otitis Media
An observational study of Acute Otitis Media, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Detection of taste changes in Acute Otitis Media (AOM) patients. Read more about this study
- Who is it for?
- Ages 8 to 40 years
- Conditions the study is for
- Acute Otitis Media
- What is being tested?
- Electrogustometery
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2018to 1 Mar 2019
- 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 8 to 40 years
- All sexes
- Child, Adult
Study population: Patients with AOM
Who may be able to join
- Unilateral AOM
Who cannot join
- Chronic Otitis Media
- Pregnancy
- Patients with lack of judgment
Trial locations and contacts
No sites are listed yet.
About this study
Detection of taste changes in Acute Otitis Media (AOM) patients.
Read the detailed description
Methods:
Taste assessment will be done using Electrogustometer (EGM). Tongue stimulation will be performed using low currents of up to 100uA. Using the protocol as specified in the EGM user manual.
Population: 40 Unilateral AOM patients, aged 8-40. Without chronic otitis media, pregnancy or impaired judgement.
- Conditions
- Acute Otitis Media
- Being tested
- Electrogustometery
- Keywords
- Acute otitis media, AOM, Electrogustometer, EGM, Taste threshold
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrogustometeryDiagnostic test
Taste assessment using EGM
| Study group | Role | What they receive |
|---|---|---|
| Patients | patients with AOM Receives: Diagnostic Test: Electrogustometery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taste change in AOM
change in taste threshold in AOM patients
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start1 Mar 2018 (estimated)
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Otitis MediaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Tel Aviv University
- Responsible party
- Sponsor
- Investigators
- Ari DeRowe, MD, Principal investigator, TLVMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315156
- Sponsor's protocol ID
- TASMC-17-AD-0311-17-TLV-CTIL
- Status last verified
- Oct 2017
- First submitted
- 16 Oct 2017
- Last updated
- 19 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taste Changes in Acute Otitis Media
- ClinicalTrials.gov ID
- NCT03315156
- Acronym / sponsor ID
- TASMC-17-AD-0311-17-TLV-CTIL
- Conditions
- Acute Otitis Media
- Keywords
- Acute otitis media, AOM, Electrogustometer, EGM, Taste threshold
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Tel Aviv University
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 19 Oct 2017 (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.
Detection of taste changes in Acute Otitis Media (AOM) patients.
Detailed description
Methods:
Taste assessment will be done using Electrogustometer (EGM). Tongue stimulation will be performed using low currents of up to 100uA. Using the protocol as specified in the EGM user manual.
Population: 40 Unilateral AOM patients, aged 8-40. Without chronic otitis media, pregnancy or impaired judgement.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: Electrogustometerypatients with AOM |
Who may qualify
- Ages
- 8 to 40 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients with AOM
Key inclusion criteria (1 listed)
- Unilateral AOM
Key exclusion criteria (3 listed)
- Chronic Otitis Media
- Pregnancy
- Patients with lack of judgment
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 |
|---|---|---|
| ElectrogustometeryTaste assessment using EGM | Diagnostic test | Patients |
Primary outcome
Taste change in AOM
Time frame: 1 week
change in taste threshold in AOM patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
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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.
Ari DeRowe, MD principal investigator
TLVMC
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Otitis Media, run by Tel-Aviv Sourasky Medical Center.
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 3 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 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Ari DeRowe, MD (03-6974517, arid@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Taste change in AOM (time frame: 1 week). 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 19 Oct 2017.