CompletedNot Applicable

Short-term Effects of Ventilation Tubes in Children With Chronic Otitis Media With Effusion

Denmark60 participantsStarted 2017-01-20

Plain-language summary

The goal of this clinical, randomized trial is to compare the sleeping patterns and quality of life of children with chronic otitis media with effusion (OME) with or without tympanic tubes insertion. The main questions it aims to answer are: * Does tympanic tube insertion have an effect on sleep quality in children with chronic OME? * Does tympanic tube insertion improve the quality of life for the children with chronic OME and their caregivers? Participants will have their movements during sleep and number of awakenings measured by an accelerometer placed on their wrist for 7 nights before and after tympanic tube insertion. Their caregivers will answer questionnaires regarding quality of life on behalf of the child. Researchers will compare with a control group of children who also is diagnosed with chronic OME. They will also have their sleep monitored for 7 nights and their caregivers will complete quality of life questionnaires, but the will not receive a tympanic tube. However the control group will be reassessed a month after baseline, and if they still qualify for tympanic tube insertion they will undergo the same routine as the intervention group.

Who can participate

Age range

1 Year – 4 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 1-4 years with chronic otitis media with effusion and subjective hearing loss * 1\. time ventilation tube insertion * At least three months with middle ear fluid in both ears before inclusion * ASA group 1 and 2 Exclusion Criteria: * Recurrent AOM * Concomitant adenoidectomy or adenotonsillectomy * Lip-gum-cleft anomalies or other craniofacial malformations * Downs syndrome * Existing sleep apnea * Asthmatic bronchitis or other chronic lung diseases like CF or other sleep disorders * ASA \> 2 * Children with hyperkinetic syndrome * Present breastfeeding during night * Not fluent in Danish language * Other systemic diseases

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 sleep quality

Timeframe: For the intervention group: 7 nights before and 7 nights after intervention. For the control group: 7 nights at time of inclusion.

Change in Quality of Life

Timeframe: At inclusion and up to 2 months follow up

Trial details

NCT IDNCT06100159

SponsorZealand University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-30

View on ClinicalTrials.gov More Otitis Media With Effusion in Children trials