Family MobilePhone Otoscopy in Diagnostics of Otitis Media

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.

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Key information

Conditions

Otitis Media Ear Diseases Otitis Otorhinolaryngologic Diseases

Age range

6 month–35 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Turku University Hospital

Turku, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teaching

Other

(CellScopeOTO)

Device

Primary outcomes

diagnostic quality of tympanic membrane imagines

Time frame: first study week

diagnostic quality of tympanic membrane imagines obtained by parents with cellphone otoscope

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Official study title

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

Acronym: FamilymOTO

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: May 22, 2015
Registry last updated: Nov 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed