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Treatment and Prevention of Middle Ear Morbidity in Head and Neck Cancer Patients Following Radiotherapy

NCT02716376 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-07-26

No results posted yet for this study

Summary

To investigate the incidence of tuba dysfunction (TD) and middle ear (ME) morbidity after radiotherapy (RT) to the Head \& Neck and test the effect of auto-inflation of the Eustachian tube (ET) on middle ear effusion with a special designed balloon (Otovent®) and thereby better hearing and ear related quality of life after cancer treatment.

Conditions

  • Otitis Media With Effusion
  • Chronic Otitis Media
  • Hearing Loss

Interventions

DEVICE

Otovent®

Otovent® is a special designed balloon that is blown up through the nose, also referred to as auto-inflation of the eustachian tube. The patients use the Otovent® 5 times a day.

Sponsors & Collaborators

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Jakob Gerlach Christensen · Køge University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2022-04-01
Completion
2022-04-01

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02716376 on ClinicalTrials.gov