NCT07639775
Osteopathic Manipulative Treatment for Children With Chronic or Recurrent Otitis Media
Not Yet Recruiting
NAAges 6–6InterventionalTreatmentSarah VidalInvestigator-initiated
~200 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:Experimental Osteopathic Manipulative Treatment (OMT) ProtocolControl Osteopathic Manipulative Treatment (OMT) Protocol
At a glance
Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Final Surgical Decision
Measured over At the time of the participant's pre-operative ENT visit, following all four study visits.
Conditions
Where it's being run
2 sites across 1 statesVirginia2
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Age 6 months to less than 7 years. (All participants)
Referred to an otolaryngologist (ENT) for evaluation of chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM). (All participants)
Planned for tympanostomy tube placement (unilateral or bilateral) pending surgical decision. (All participants)
At least 5 weeks between enrollment and anticipated surgical decision point. (All participants)
Exclusion
Congenital or developmental conditions associated with increased otitis media risk, including but not limited to Down syndrome, cleft palate, or other craniofacial abnormalities. (All participants)
History of prior tympanostomy tube placement or current tympanostomy tubes in place. (All participants)
History of tympanic membrane perforation. (All participants)
Presence of preauricular pits. (All participants)
Patients requiring urgent or expedited surgical intervention, as determined by the treating ENT physician. (All participants)
What this trial measures
- Final Surgical DecisionAt the time of the participant's pre-operative ENT visit, following all four study visits.
Following the final intervention for any given participant, the ENT physician, in conjunction with the parent/guardian, will determine whether to proceed with tympanostomy tube placement, defer, or cancel based on clinical status. This decision constitutes the primary outcome of the study.