Family MobilePhone Otoscopy in Diagnostics of Otitis Media

Overview

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.

Full Title of Study: “Family MobilePhone Otoscopy in Diagnostics of Otitis Media. (Family mOTO-Study)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2016

Interventions

  • Other: Teaching
  • Device: (CellScopeOTO)

Arms, Groups and Cohorts

  • Active Comparator: Teaching group
    • Parents are taught to conduct cellphone otoscopy and if necessary study physician removes cerumen from childrens´ ear canals at the first study visit.
  • Other: Control group
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • diagnostic quality of tympanic membrane imagines
    • Time Frame: first study week
    • diagnostic quality of tympanic membrane imagines obtained by parents with cellphone otoscope

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 35 Months

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Turku University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Aino Ruohola, MD, PhD, Principal Investigator, consultant

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