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

NCT06100159 | Completed

• 1 other identifier: REG-131-2015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Otitis Media With Effusion in Children; Quality of Life; Sleep

Outcome Measures

Primary Outcomes (2)

• Change in sleep quality

  Sleep length and quality. An accelerometer is fitted on the participants and measures movement in 3 axis. The movement counts from the acclerometer will be processed by Sadeh's algorithm giving assessed minutes of total sleep, awakenings and sleep quality. The outcome will be assessed by a blinded investigator.

  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

  Quality of life quantified by the validated questionnaire OM-6. 7-point Likert scale where 1 is no problem and 7 is extreme problem. The global NRS scales were 10 point scales with o = worst possible QoL and 10 = best possible QoL

  At inclusion and up to 2 months follow up

Secondary Outcomes (1)

• Use of pain reliever

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

Study Arms (2)

Tympanostomy tube

EXPERIMENTAL

Insertion of tympanostomy tubes after 3 months observation for chronic otitis media with effusion (OME) according to the National guidelines in Denmark. Sleep measurements with accelerometer 7 nights before and 7 nights after intervention. Caregivers report use of paracetamol during nights with sleep measurements.

Device: Tympanostomy tube insertion

Control

NO INTERVENTION

No tympanostomy tube treatment up to 1 month after enrollment in control group. Sleep measurements with accelerometer 7 nights at time of inclusion. Caregivers report use of paracetamol during nights with sleep measurements. After 1 month tympanic tube insertion is allowed if still chronic OME. If tympanostomy tubes are needed the children will undergo same evaluation as the intervention group.

Interventions

Tympanostomy tube insertion DEVICE

Ventilation tube insertion in the tympanic membrane

Also known as: ventilation tube, grommet

Tympanostomy tube

Eligibility Criteria

• Age: 1 Year - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 1-4 years with chronic otitis media with effusion and subjective hearing loss
• \. time ventilation tube insertion
• ASA group 1 and 2

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead
• Danish Medical Association: collaborator

Study Sites (2)

Ørelægerne Fredericia

Fredericia, 7000, Denmark

Location

Peter Tingsgaard

Slagelse, Denmark

Location

MeSH Terms

Interventions

Middle Ear Ventilation

Intervention Hierarchy (Ancestors)

Ostomy; Surgical Procedures, Operative; Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures

Study Officials

• Preben Homoee, MD

  Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: questionnaires and sleep outcome measures will be assessed by masked person
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: RCT with an intervention and a control group

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: October 25, 2023
• Study Start: January 20, 2017
• Primary Completion: June 30, 2022
• Study Completion: August 30, 2022
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

DK (2)