CompletedNot Applicable

Osteopathic Otitis Media Research Study

United States52 participantsStarted 2007-09

Plain-language summary

The purpose of this study is to determine if the application of osteopathic manipulative medicine speeds the rate of resolution of middle ear effusion (fluid) in children following an episode of acute otitis media.

Who can participate

Age range

6 Months – 2 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 6 months up to second birthday * Documented presence of acute otitis media following the 2004 AAP/AAFP Guidelines within 3 days of entry into the study Exclusion Criteria: * Chromosomal abnormalities * Major congenital malformations of the head and neck, including torticollis * Immunologic abnormalities or deficiencies * Any prior ear-nose-throat surgery performed as a treatment for otitis media * Any tube placement surgery scheduled during the four weeks of the study. * Normal tympanograms at entry into study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Middle Ear Effusion Over Four Weeks Following an Episode of Acute Otitis Media

Timeframe: 1 month

Trial details

NCT IDNCT00520039

SponsorWest Virginia School of Osteopathic Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-08

Results submitted2016-11-10

View on ClinicalTrials.gov More Otitis Media With Effusion trials

Who can participate

Age range

6 Months – 2 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.