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CompletedNCT02452164FamilymOTOUpdated Nov 16, 2016

Family MobilePhone Otoscopy in Diagnostics of Otitis Media

An interventional study of Teaching and (CellScopeOTO) in Otitis Media, sponsored by Turku University Hospital. Completed at 1 site in Finland. Open to participants aged 6 Months to 35 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-16.

Sponsored by Turku University Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
6 Months to 35 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Otitis Media

Keywords

  • otoscopy
  • otitis media
  • cellphone
  • family
03

In context

Otitis

246 studies on the registry are indexed under Otitis; 21 are open to participants now.

This study's enrollment of 41 is below the median of 126 across 173 interventional studies indexed under Otitis.

Browse Otitis studies →

Lead sponsor

Turku University Hospital is the lead sponsor of 280 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Months to 35 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • 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: Teaching · Device: (CellScopeOTO)

  • 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.

    Device: (CellScopeOTO)

Interventions

  • OtherTeaching
  • Device(CellScopeOTO)
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What researchers measure

Primary outcomes

  1. diagnostic quality of tympanic membrane imagines

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

    Time frame: first study week

07

Study locations

1 site
  • Turku University Hospital
    Turku, Finland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02452164
Lead sponsor
Turku University Hospital
Responsible party
Sponsor
First posted
May 22, 2015
Start date
Sep 2015
Primary completion
Apr 2016
Completion
Apr 2016
Last update
Nov 16, 2016

Study contacts

Aino Ruohola, MD, PhD
principal investigator · consultant

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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