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
• 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

• Otitis
• Otitis Media

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