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Ear tubes may improve sleep and quality of life in toddlers with chronic ear fluid

NCT ID NCT06100159

Symptom relief Sponsor: Zealand University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether placing small tubes in the ears of children aged 1-4 with chronic ear fluid (otitis media with effusion) improves their sleep and quality of life. Sixty children were randomly assigned to either receive ear tubes or not. Sleep was measured with a wrist-worn activity monitor, and parents filled out quality-of-life questionnaires. The goal was to see if the tubes help children sleep better and improve daily life for both kids and their caregivers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Jan 2017

Finished

Aug 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 4 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

otitis media with effusion sleep disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Otitis media with effusion in children Quality of life Sleep

Contacts and locations

Locations

  • Peter Tingsgaard

    Slagelse, Denmark

  • Ørelægerne Fredericia

    Fredericia, 7000, Denmark

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Other studies related to the condition(s) this trial covers.