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Family MobilePhone Otoscopy in Diagnostics of Otitis Media

NCT ID: NCT02452164

Last Updated: 2016-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Otitis Media

Keywords

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otoscopy otitis media cellphone family

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Teaching

Intervention Type OTHER

(CellScopeOTO)

Intervention Type DEVICE

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.

Group Type OTHER

(CellScopeOTO)

Intervention Type DEVICE

Interventions

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Teaching

Intervention Type OTHER

(CellScopeOTO)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

35 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aino Ruohola, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

consultant

Locations

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Turku University Hospital

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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T91/2015

Identifier Type: -

Identifier Source: org_study_id