Otitis Media With EffusionNCT00547326
The Effect of Osteopatic Cranial Techniques on the Audiometric and Tympanometric Values in Children Suffering From Otitis Media With Effusion.
A study testing treated with osteopatic cranial techniques in people with Otitis Media With Effusion, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Otitis Media With Effusion
- What is being tested?
- treated with osteopatic cranial techniques
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children between 3 and 7 years old
- Bilateral otitis media with effusion
- Tympanogram type B
Who cannot join
- ventilation tubes
- Damage of the tympanic membrane
- Operation of the tympanic membrane
- Other illness e.g. Down, craniofacial abnormalities,…
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Otitis Media With Effusion
- Being tested
- treated with osteopatic cranial techniques, Treatment with placebo
- Medical subject headings
- Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treated with osteopatic cranial techniquesProcedure or surgery
treated with osteopatic cranial techniques
Treatment with placeboProcedure or surgery
Treatment with placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatement with osteopatic cranial techniques Receives: Procedure: treated with osteopatic cranial techniques |
| 2 | Placebo comparator | Treatment with placebo Receives: Procedure: Treatment with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Audiometric and tympanometric results
Measured: directly after every session of treatment (3 times, once a week)
Secondary outcomes (1)
Audiometric and tympanometric results
Measured: one week after the last treatment session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2007 (estimated)
Why it stopped: Ethics Committee approval denied
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis Media With EffusionStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- I. Dhooge, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547326
- Sponsor's protocol ID
- 2007/397
- Status last verified
- Jul 2021
- First submitted
- 19 Oct 2007
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Osteopatic Cranial Techniques on the Audiometric and Tympanometric Values in Children Suffering From Otitis Media With Effusion.
- ClinicalTrials.gov ID
- NCT00547326
- Acronym / sponsor ID
- 2007/397
- Conditions
- Otitis Media With Effusion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Ethics Committee approval denied
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- First posted
- 22 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: treated with osteopatic cranial techniquesTreatement with osteopatic cranial techniques |
| 2 | Placebo comparator | Procedure: Treatment with placeboTreatment with placebo |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children between 3 and 7 years old
- Bilateral otitis media with effusion
- Tympanogram type B
Key exclusion criteria (4 listed)
- ventilation tubes
- Damage of the tympanic membrane
- Operation of the tympanic membrane
- Other illness e.g. Down, craniofacial abnormalities,…
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| treated with osteopatic cranial techniquestreated with osteopatic cranial techniques | Procedure or surgery | 1 |
| Treatment with placeboTreatment with placebo | Procedure or surgery | 2 |
Primary outcome
Audiometric and tympanometric results
Time frame: directly after every session of treatment (3 times, once a week)
1 secondary outcome
Audiometric and tympanometric results
Time frame: one week after the last treatment session.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Website University Hospital GhentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
I. Dhooge, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treated with osteopatic cranial techniques in people with Otitis Media With Effusion, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Audiometric and tympanometric results (time frame: directly after every session of treatment (3 times, once a week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021; AzTrials last refreshed its copy on 7 Nov 2026.