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NCT04864912

Retrospective Health Care Utilisation and Current Quality of Life in Adults With Chronic Otitis Media Who Had a Middle Ear Surgery

Completed Results posted Last updated 7 March 2025
What this trial tests

trial testing Questionnaires and survey in Chronic Otitis Media in 69 participants. Completed in 9 October 2023.

Timeline
1 February 2022
Primary endpoint
9 October 2023
9 October 2023

Quick facts

Lead sponsorCochlear
StatusCompleted
Study typeOBSERVATIONAL
Enrollment69
Start date1 February 2022
Primary completion9 October 2023
Estimated completion9 October 2023
Sites6 locations across France, Germany, Spain

Drugs / interventions tested

Conditions studied

Sponsor

Cochlear — full company profile →

Who can join

18 and older, any sex, with Chronic Otitis Media. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number and Type of Contacts With Health Care Providers Primary · From primary tympanoplasty to time of enrolment, up to 13 years

Contacts are obtained from medical records, counted and categorized.

Contact for 1 surgical procedure
GroupValue95% CI
Observational Cohort45
Contact for 2 surgical procedures
GroupValue95% CI
Observational Cohort14
Contact for 3 surgical procedures
GroupValue95% CI
Observational Cohort5
Contact for 4 surgical procedures
GroupValue95% CI
Observational Cohort3
Contact for more than four surgical procedures
GroupValue95% CI
Observational Cohort2
Contact for 2 audiograms
GroupValue95% CI
Observational Cohort45
Contact for 3 audiograms
GroupValue95% CI
Observational Cohort5
Contact for 4 audiograms
GroupValue95% CI
Observational Cohort3
Number and Type of Interventions and/or Procedures Primary · From primary tympanoplasty to time of enrolment, up to 13 years

Medical examinations, surgical procedures and hearing rehabilitation are obtained from medical records, counted and categorized.

CT scan of the temporal bone and/or sinuses
GroupValue95% CI
Observational Cohort12
MRI of the temporal bone or the brain
GroupValue95% CI
Observational Cohort23
another medical examination
GroupValue95% CI
Observational Cohort14
primary tympanoplasty
GroupValue95% CI
Observational Cohort65
revision surgeries
GroupValue95% CI
Observational Cohort25
planned staged or second look surgeries
GroupValue95% CI
Observational Cohort18
Number and Type of Medications and Therapies Primary · From primary tympanoplasty to time of enrolment, up to 13 years

Medications are obtained from medical records, counted and categorized. Therapies from medical records are listed.

Antiinfective
GroupValue95% CI
Observational Cohort20
Analgesics and anesthetics
GroupValue95% CI
Observational Cohort1
Anilides
GroupValue95% CI
Observational Cohort14
Antivertigo preparations
GroupValue95% CI
Observational Cohort3
Benzodiazepine derivatives
GroupValue95% CI
Observational Cohort1
Combinations of penicillins, incl. beta-lactamase inhibitors
GroupValue95% CI
Observational Cohort4
Corticosteroids
GroupValue95% CI
Observational Cohort5
Corticosteroids and antiinfectives in combination
GroupValue95% CI
Observational Cohort12
Hearing Performance Assessed Via an Audiogram Secondary · Up to 12 months prior to primary tympanoplasty

PTA4 (0.5, 1, 2 and 4 kHz) for both air and bone conduction, under unaided and when applicable aided conditions. Data obtained from participant medical records.

Air Conduction
GroupValue95% CI
Observational Cohort53.2± 19.64
Bone Conduction
GroupValue95% CI
Observational Cohort23.8± 14.76
Hearing Performance Assessed Via an Audiogram Secondary · Within 12 months after primary tympanoplasty

PTA4 (0.5, 1, 2 and 4 kHz) for both air and bone conduction, under unaided and when applicable aided conditions. Data obtained from participant medical records.

Air Conduction
GroupValue95% CI
Observational Cohort58.7± 14.9
Bone conduction
GroupValue95% CI
Observational Cohort25.3± 14.85
Hearing Performance Assessed Via an Audiogram Secondary · Up to 6 years prior to study enrollment

PTA4 (0.5, 1, 2 and 4 kHz) for both air and bone conduction, under unaided and when applicable aided conditions. Data obtained from participant medical records.

Air conduction
GroupValue95% CI
Observational Cohort56.7± 21.16
Bone conduction
GroupValue95% CI
Observational Cohort25.2± 13.89
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey Secondary · At enrolment

Demographic data, medical history, hearing rehabilitation, health care utilisation related to ear infection and hearing difficulties and employment information data are collected.

married/living as married
GroupValue95% CI
Observational Cohort41
single
GroupValue95% CI
Observational Cohort14
widowed
GroupValue95% CI
Observational Cohort7
divorced/separated
GroupValue95% CI
Observational Cohort6
living with spouse/partner and children
GroupValue95% CI
Observational Cohort24
living with spouse/partner without children
GroupValue95% CI
Observational Cohort19
living alone
GroupValue95% CI
Observational Cohort13
living with their parents
GroupValue95% CI
Observational Cohort6
Self-reported Health Status and Health Related Quality of Life Via the Health Utilities Index Mark III (HUI3) Questionnaire. Secondary · At enrolment

HUI provides descriptive evidence on multiple dimensions of health status, a score for each dimension of health and an overall Health Related Quality of life score. The HUI3 classification system is comprised of 8 attributes: Vision, Hearing, Speech, Ambulation, Dexterity, Emotion, Cognition and Pain - each with 5 or 6 levels of ability/disability The scoring systems provide utility (preference) scores on a generic scale where 0.00 indicates death and 1.00 indicates perfect health.

Overall
GroupValue95% CI
Observational Cohort0.7± 0.28
Vision
GroupValue95% CI
Observational Cohort0.9± 0.17
Hearing
GroupValue95% CI
Observational Cohort0.8± 0.29
Speech
GroupValue95% CI
Observational Cohort0.9± 0.15
Dexterity
GroupValue95% CI
Observational Cohort1± 0.11
Emotion
GroupValue95% CI
Observational Cohort0.9± 0.16
Cognition
GroupValue95% CI
Observational Cohort0.9± 0.14
Pain
GroupValue95% CI
Observational Cohort0.9± 0.19
Self-reported Health Related Quality of Life of Participants With COM Via the Chronic Otitis Media Outcome Test-15 (COMOT-15) Questionnaire. Secondary · At enrolment

COMOT-15 measures Health Related Quality of life of participants with COM. It consists of three subscales: ear symptoms, hearing function, and mental health forming the overall score. In addition, two questions related to COM are asked: one on the general evaluation of quality of life and one on the frequency of doctor visits in the last six months. The total score and the sub-scores are transformed to a 0-100 scale by dividing the sum of the raw scores of the items by the sum of spans of the items, then multiplying by 100. A higher score indicates a worse health-related quality of life.

Overall
GroupValue95% CI
Observational Cohort43± 18.25
Ear symptoms
GroupValue95% CI
Observational Cohort29.4± 20.28
Hearing function
GroupValue95% CI
Observational Cohort65± 22.84
Mental Health
GroupValue95% CI
Observational Cohort46.5± 27.31
Self-reported Auditory Disability Via the Speech, Spatial and Qualities of Hearing Scale (SSQ-12) Questionnaire Secondary · At enrolment

SSQ-12 measures speech, spatial and hearing experiences. The total(overall) score summarizes these parameters. A scale from 0 to 10 is used. A mark 0 means "be quite unable to do or experience what is described" and a mark 10 means "be perfectly able to do or experience what is described in the question".

GroupValue95% CI
Observational Cohort5.5± 2.18
Chronic Otitis Media Outcome Test -15 (COMOT-15) Questionnaire in German, French and Spanish Secondary · At enrollment

Mean score of Chronic Otitis Media Outcome Test -15 (COMOT-15) in German, French and Spanish (0-100 scale). This questionnaire consists of 15 questions that query 3 subscales: ear symptoms, hearing function, and mental health. Additionally, it includes a question about quality of life and specialist doctor visit frequency. The total score is summed, transformed and presented on a 0 - 100 scale where 0 is a good outcome and 100 is the worst possible outcome.

German
GroupValue95% CI
Observational Cohort36.8± 14.76
French
GroupValue95% CI
Observational Cohort46.3± 22.73
Spanish
GroupValue95% CI
Observational Cohort45± 17.12

Sponsor's own description

The objective of this multicentre study is to evaluate the standard of care of participants diagnosed with Chronic Otitis Media that have already gone through a first middle ear surgery but still have at least a moderate hearing loss. The study has a retrospective part (extraction of medical chart data) and a prospective part with a survey and three questionnaires collecting data on the use of health care services, on health related quality of life and hearing performance.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Long-term outcomes of tympanoplasty with persistent air-bone gap in adults with chronic otitis media: hearing, health care utilization and quality of life.
    Arndt S, Deguine O, Nevoux J, Sánchez S, et al · · 2025 · PMID 40329039 · DOI 10.1007/s00405-025-09421-w

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing