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NCT02452164 Clinical Trial

Family MobilePhone Otoscopy in Diagnostics of Otitis Media

Otitis Media Clinical Trial

— FamilymOTO  

Official title:
Family MobilePhone Otoscopy in Diagnostics of Otitis Media. (Family mOTO-Study)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02452164
Other study ID # T91/2015
Secondary ID
Status Completed
Phase N/A
First received May 20, 2015
Last updated November 15, 2016
Start date September 2015
Est. completion date April 2016

Study information
Verified date November 2016
Source Turku University Hospital
Contact n/a
Is FDA regulated No
Health authority Finland: Valvira - National Supervisory Authority for Welfare and Health
Study type Interventional

Clinical 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). 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.

Recruitment information / eligibility
Status Completed
Enrollment 41
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Months to 35 Months
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Other:
• Teaching

Device:
• (CellScopeOTO)

Locations
Country Name City State
Finland Turku University Hospital Turku

Sponsors (1)
Lead Sponsor Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary diagnostic quality of tympanic membrane imagines diagnostic quality of tympanic membrane imagines obtained by parents with cellphone otoscope first study week No
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