Back to resultsThe Effect of Osteopatic Cranial Techniques on the Audiometric and Tympanometric Values in Children Suffering From Otitis Media With Effusion.
Primary Purpose
Otitis Media With Effusion
Status
Withdrawn
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
treated with osteopatic cranial techniques
Treatment with placebo
Sponsored by
About this trial
This is an interventional treatment trial for Otitis Media With Effusion
Eligibility Criteria
Inclusion Criteria:
- children between 3 and 7 years old
- Bilateral otitis media with effusion
- Tympanogram type B
Exclusion Criteria:
- ventilation tubes
- Damage of the tympanic membrane
- Operation of the tympanic membrane
- Other illness e.g. Down, craniofacial abnormalities,…
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Treatement with osteopatic cranial techniques
Treatment with placebo
Outcomes
Primary Outcome Measures
Audiometric and tympanometric results
Secondary Outcome Measures
Audiometric and tympanometric results
Full Information
NCT ID
NCT00547326
First Posted
October 19, 2007
Last Updated
July 5, 2021
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT00547326
Brief Title
The Effect of Osteopatic Cranial Techniques on the Audiometric and Tympanometric Values in Children Suffering From Otitis Media With Effusion.
Official Title
The Effect of Osteopatic Cranial Techniques on the Audiometric and Tympanometric Values in Children Suffering From Otitis Media With Effusion.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Ethics Committee approval denied
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media With Effusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Treatement with osteopatic cranial techniques
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Treatment with placebo
Intervention Type
Procedure
Intervention Name(s)
treated with osteopatic cranial techniques
Intervention Description
treated with osteopatic cranial techniques
Intervention Type
Procedure
Intervention Name(s)
Treatment with placebo
Intervention Description
Treatment with placebo
Primary Outcome Measure Information:
Title
Audiometric and tympanometric results
Time Frame
directly after every session of treatment (3 times, once a week)
Secondary Outcome Measure Information:
Title
Audiometric and tympanometric results
Time Frame
one week after the last treatment session.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children between 3 and 7 years old
Bilateral otitis media with effusion
Tympanogram type B
Exclusion Criteria:
ventilation tubes
Damage of the tympanic membrane
Operation of the tympanic membrane
Other illness e.g. Down, craniofacial abnormalities,…
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
I. Dhooge, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website University Hospital Ghent
Learn more about this trial
The Effect of Osteopatic Cranial Techniques on the Audiometric and Tympanometric Values in Children Suffering From Otitis Media With Effusion.
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