NCT00547326

Brief Summary

Children with otitis media with effusion will be treated with osteopatic cranial techniques or with a placebo treatment. Before and after the treatment audiometric and tympanometric measures will take place. This procedure will be repeated 3 times, once a week and every session will last for 30-45 minutes. The fourth week, only audiometry and tympanomtry will be done.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 22, 2007

Completed
Last Updated

July 7, 2021

Status Verified

July 1, 2021

First QC Date

October 19, 2007

Last Update Submit

July 5, 2021

Conditions

Otitis Media With Effusion

Outcome Measures

Primary Outcomes (1)

  • Audiometric and tympanometric results

    directly after every session of treatment (3 times, once a week)

Secondary Outcomes (1)

  • Audiometric and tympanometric results

    one week after the last treatment session.

Study Arms (2)

1

EXPERIMENTAL

Treatement with osteopatic cranial techniques

Procedure: treated with osteopatic cranial techniques

2

PLACEBO COMPARATOR

Treatment with placebo

Procedure: Treatment with placebo

Interventions

treated with osteopatic cranial techniquesPROCEDURE

treated with osteopatic cranial techniques

1
Treatment with placeboPROCEDURE

Treatment with placebo

2

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children between 3 and 7 years old
  • Bilateral otitis media with effusion
  • Tympanogram type B

You may not qualify if:

  • ventilation tubes
  • Damage of the tympanic membrane
  • Operation of the tympanic membrane
  • Other illness e.g. Down, craniofacial abnormalities,…

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Conditions

Otitis Media with Effusion

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Otitis MediaOtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • I. Dhooge, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2007

First Posted

October 22, 2007

Last Updated

July 7, 2021

Record last verified: 2021-07

Locations

BE(1)