Otitis MediaFamilymOTONCT02452164
Family MobilePhone Otoscopy in Diagnostics of Otitis Media
A study testing Teaching and (CellScopeOTO) in people with Otitis Media, run by Turku University Hospital at 1 site in Finland.
Trial summary
This is a one-center clinical study carried out in Turku, Finland. The study patients will be randomly allocated to one of the two parallel study groups (teaching group and control group). Read more about this study
- Who is it for?
- Ages 6 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Otitis Media
- What is being tested?
- Teaching and (CellScopeOTO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2015to Apr 2016
- 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 6 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 6 - 35 mo
- Parents have iPhone 5, 5s or 6
- Child is in daycare
- Child has had at least one acute otitis media within 90 days preceding the enrollment
- Family agrees to give a mortgage of 40 euros from the CellScopeOTO
Who cannot join
- Tympastonomy tube present in tympanic membrane
- Chronic perforation of the tympanic membrane
- Condition of head/neck anomaly to affect middle ear or ear canal anatomy
- One child from the family already participating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Family MobilePhone Otoscopy in Diagnostics of Otitis Media. (Family mOTO-Study)
This is a one-center clinical study carried out in Turku, Finland. The study patients will be randomly allocated to one of the two parallel study groups (teaching group and control group). The hypothesis is that the diagnostic quality of tympanic membrane imagines is better when parents have been taught to conduct middle ear examination with a cellphone otoscope (CellScopeOTO) as compared to no teaching. Furthermore, this study aims at evaluating the diagnostic feasibility of cellphone otoscopy.
- Conditions
- Otitis Media
- Being tested
- Teaching, (CellScopeOTO)
- Keywords
- otoscopy, otitis media, cellphone, family
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeachingOther
(CellScopeOTO)Device
| Study group | Role | What they receive |
|---|---|---|
| Teaching group | Active comparator | Parents are taught to conduct cellphone otoscopy and if necessary study physician removes cerumen from childrens´ ear canals at the first study visit. Receives: Other: Teaching; Device: (CellScopeOTO) |
| Control group | Other | Families receive the cellphone otoscope as if they had bought it themselves from the internet. After the first study week, parents are taught to conduct cellphone otoscopy and if necessary study physician removes cerumen from childrens´ ear canals. Receives: Device: (CellScopeOTO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic quality of tympanic membrane imagines
diagnostic quality of tympanic membrane imagines obtained by parents with cellphone otoscope
Measured: first study week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startSep 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis MediaStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Aino Ruohola, MD, PhD, Principal investigator, consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452164
- Sponsor's protocol ID
- T91/2015
- Acronym
- FamilymOTO
- Status last verified
- Nov 2016
- First submitted
- 20 May 2015
- Last updated
- 16 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family MobilePhone Otoscopy in Diagnostics of Otitis Media. (Family mOTO-Study)
- ClinicalTrials.gov ID
- NCT02452164
- Acronym / sponsor ID
- FamilymOTO / T91/2015
- Conditions
- Otitis Media
- Keywords
- otoscopy, otitis media, cellphone, family
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Sep 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 22 May 2015 (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.
This is a one-center clinical study carried out in Turku, Finland. The study patients will be randomly allocated to one of the two parallel study groups (teaching group and control group). The hypothesis is that the diagnostic quality of tympanic membrane imagines is better when parents have been taught to conduct middle ear examination with a cellphone otoscope (CellScopeOTO) as compared to no teaching. Furthermore, this study aims at evaluating the diagnostic feasibility of cellphone otoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teaching group | Active comparator | Other: Teaching, Device: (CellScopeOTO)Parents are taught to conduct cellphone otoscopy and if necessary study physician removes cerumen from childrens´ ear canals at the first study visit. |
| Control group | Other | Device: (CellScopeOTO)Families receive the cellphone otoscope as if they had bought it themselves from the internet. After the first study week, parents are taught to conduct cellphone otoscopy and if necessary study physician removes cerumen from childrens´ ear canals. |
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 6 - 35 mo
- Parents have iPhone 5, 5s or 6
- Child is in daycare
- Child has had at least one acute otitis media within 90 days preceding the enrollment
- Family agrees to give a mortgage of 40 euros from the CellScopeOTO
Key exclusion criteria (4 listed)
- Tympastonomy tube present in tympanic membrane
- Chronic perforation of the tympanic membrane
- Condition of head/neck anomaly to affect middle ear or ear canal anatomy
- One child from the family already participating
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 |
|---|---|---|
| Teaching | Other | Teaching group |
| (CellScopeOTO) | Device | Control group, Teaching group |
Primary outcome
diagnostic quality of tympanic membrane imagines
Time frame: first study week
diagnostic quality of tympanic membrane imagines obtained by parents with cellphone otoscope
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 16 Nov 2016.
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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.
Aino Ruohola, MD, PhD principal investigator
consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teaching and (CellScopeOTO) in people with Otitis Media, run by Turku University Hospital at 1 site in Finland.
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 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: finished, as of the sponsor's last update on 16 Nov 2016. 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 Finland. 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?
diagnostic quality of tympanic membrane imagines (time frame: first study 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 16 Nov 2016.