Chronic Otitis MediaNCT04864912
Retrospective Health Care Utilisation and Current Quality of Life in Adults With Chronic Otitis Media Who Had a Middle Ear Surgery
An observational study of Chronic Otitis Media, run by Cochlear at 6 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Otitis Media
- What is being tested?
- Questionnaires and survey
- How many people
- 69 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 1 Feb 2022to 9 Oct 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with a history of chronic otitis media who have undergone a primary tympanoplasty to improve hearing between 2010-2016 but still have conductive or mixed hearing loss.
Who may be able to join
- Adult subjects, 18 years or older.
- Subjects with conductive or mixed hearing loss.
- Subjects with historically documented diagnosis of Chronic Otitis Media (COM) with or without cholesteatoma in the operated ear.
- Subjects who have undergone primary tympanoplasty type I-V to improve hearing between 2010-2016.
- Subjects with a Pure Tone Average (PTA)4 air-bone gap ≥30 decibels (dB) OR PTA4 air-bone gap between 25-30 dB with an air conduction threshold PTA4 ≥40 dB HL within 12 months after primary tympanoplasty in the operated ear.
- Subjects who have been recommended by their health care professional to try a hearing aid to improve hearing in the operated ear.
Show all 11Show fewer
- Pre-op audiogram, maximum 1 year prior to the primary tympanoplasty, and post-op audiogram for the primary tympanoplasty are available.
- Aided audiogram, unaided if no hearing device is used, available between 2018 and the point of enrolment.
- Subjects are fluent in the language used for study questionnaires: German, French, Spanish.
- Subjects are willing and able to provide written informed consent. For France: subjects do not oppose to participate in the study.
- Medical Record data is available throughout the defined data search period, from primary tympanoplasty to point of enrolment.
Who cannot join
- Subjects are unable or unwilling to comply with the requirements of the study as determined by the investigator.
- Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this study.
- For France only:
- Subjects who are not affiliated to social security.
- Subjects who are under legal protection.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
France2 sites
Hôpital Bicêtre, Hôpitaux universitaires Paris Sud AP-HP
Le Kremlin-Bicêtre, 94275
ENT department - Bâtiment Pierre Paul Riquet - Hôpital Purpan
Toulouse, 31059
Germany2 sites
Universitätsklinik für Hals-, Nasen und Ohrenheilkunde
Freiburg im Breisgau, 79106
Hals-, Nasen- und Ohrenklinik, Universitätsklinikum Heidelberg
Heidelberg, 69120
Spain2 sites
Hospital Universitario Donostia
Donostia / San Sebastian, 20080
Hospital Universitario Virgen Macarena
Seville, 41009
About this study
Official title: A Retrospective Mapping of Health Care Utilisation and Current Quality of Life Status in Adult Subjects With a History of Chronic Otitis Media With or Without Cholesteatoma Who Have Undergone a Primary Tympanoplasty
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.
- Conditions
- Chronic Otitis Media
- Being tested
- Questionnaires and survey
- Keywords
- Primary tympanoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires and surveyOther
Questionnaires: Health Utilities Index Mark III, Chronic Otitis Media Outcome Test-15 and Speech, Spatial, and Qualities of Hearing Scale-12 Survey: Client Service Receipt Inventory (adapted version)
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Type of Contacts With Health Care Providers
Contacts are obtained from medical records, counted and categorized.
Measured: From primary tympanoplasty to time of enrolment, up to 13 years
Number and Type of Interventions and/or Procedures
Medical examinations, surgical procedures and hearing rehabilitation are obtained from medical records, counted and categorized.
Measured: From primary tympanoplasty to time of enrolment, up to 13 years
Number and Type of Medications and Therapies
Medications are obtained from medical records, counted and categorized. Therapies from medical records are listed.
Measured: From primary tympanoplasty to time of enrolment, up to 13 years
Secondary outcomes (9)
Hearing Performance Assessed Via an Audiogram
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.
Measured: Up to 12 months prior to primary tympanoplasty
Hearing Performance Assessed Via an Audiogram
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.
Measured: Within 12 months after primary tympanoplasty
Hearing Performance Assessed Via an Audiogram
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.
Measured: Up to 6 years prior to study enrollment
Health Care Costs
Direct medical costs were calculated by applying the reported Diagnosis Related Group (DRG) codes for Chronic Otitis Media related health care utilization were obtained to the unit cost in each participating country for each participant.
Note: No outcome measures are reported as there was insufficient data collection
Measured: From primary tympanoplasty to time of enrolment.
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
Demographic data, medical history, hearing rehabilitation, health care utilisation related to ear infection and hearing difficulties and employment information data are collected.
Measured: At enrolment
Self-reported Health Status and Health Related Quality of Life Via the Health Utilities Index Mark III (HUI3) Questionnaire.
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.
Measured: At enrolment
Self-reported Health Related Quality of Life of Participants With COM Via the Chronic Otitis Media Outcome Test-15 (COMOT-15) Questionnaire.
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.
Measured: At enrolment
Self-reported Auditory Disability Via the Speech, Spatial and Qualities of Hearing Scale (SSQ-12) Questionnaire
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".
Measured: At enrolment
Chronic Otitis Media Outcome Test -15 (COMOT-15) Questionnaire in German, French and Spanish
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.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start1 Feb 2022
- Primary completion9 Oct 2023
- Study completion9 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Otitis MediaStudies of the same condition, open and under way.
- More trials run by CochlearThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- QbD Clinical, Suministros Hospitalarios Medical Group
- Responsible party
- Sponsor
- Investigators
- Christiane D'hondt, Study director, Cochlear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864912
- Sponsor's protocol ID
- CBAS5780
- Status last verified
- Feb 2025
- First submitted
- 13 Apr 2021
- Last updated
- 7 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Mapping of Health Care Utilisation and Current Quality of Life Status in Adult Subjects With a History of Chronic Otitis Media With or Without Cholesteatoma Who Have Undergone a Primary Tympanoplasty
- ClinicalTrials.gov ID
- NCT04864912
- Acronym / sponsor ID
- CBAS5780
- Conditions
- Chronic Otitis Media
- Keywords
- Primary tympanoplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Collaborators
- QbD Clinical, Suministros Hospitalarios Medical Group
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 9 Oct 2023 (actual)
- Study completion
- 9 Oct 2023 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Posted 7 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with a history of chronic otitis media who have undergone a primary tympanoplasty to improve hearing between 2010-2016 but still have conductive or mixed hearing loss.
Key inclusion criteria (11 listed)
- Adult subjects, 18 years or older.
- Subjects with conductive or mixed hearing loss.
- Subjects with historically documented diagnosis of Chronic Otitis Media (COM) with or without cholesteatoma in the operated ear.
- Subjects who have undergone primary tympanoplasty type I-V to improve hearing between 2010-2016.
- Subjects with a Pure Tone Average (PTA)4 air-bone gap ≥30 decibels (dB) OR PTA4 air-bone gap between 25-30 dB with an air conduction threshold PTA4 ≥40 dB HL within 12 months after primary tympanoplasty in the operated ear.
Key exclusion criteria (6 listed)
- Subjects are unable or unwilling to comply with the requirements of the study as determined by the investigator.
- Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this study.
- Subjects who are not affiliated to social security.
- Subjects who are under legal protection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires and surveyQuestionnaires: Health Utilities Index Mark III, Chronic Otitis Media Outcome Test-15 and Speech, Spatial, and Qualities of Hearing Scale-12 Survey: Client Service Receipt Inventory (adapted version) | Other | – |
Primary outcome
Number and Type of Contacts With Health Care Providers
Time frame: From primary tympanoplasty to time of enrolment, up to 13 years
Contacts are obtained from medical records, counted and categorized.
Number and Type of Interventions and/or Procedures
Time frame: 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.
Number and Type of Medications and Therapies
Time frame: 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.
9 secondary outcomes
Hearing Performance Assessed Via an Audiogram
Time frame: Up to 12 months prior to primary tympanoplasty
Hearing Performance Assessed Via an Audiogram
Time frame: Within 12 months after primary tympanoplasty
Hearing Performance Assessed Via an Audiogram
Time frame: Up to 6 years prior to study enrollment
Health Care Costs
Time frame: From primary tympanoplasty to time of enrolment.
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
Time frame: At enrolment
Self-reported Health Status and Health Related Quality of Life Via the Health Utilities Index Mark III (HUI3) Questionnaire.
Time frame: At enrolment
Self-reported Health Related Quality of Life of Participants With COM Via the Chronic Otitis Media Outcome Test-15 (COMOT-15) Questionnaire.
Time frame: At enrolment
Self-reported Auditory Disability Via the Speech, Spatial and Qualities of Hearing Scale (SSQ-12) Questionnaire
Time frame: At enrolment
Chronic Otitis Media Outcome Test -15 (COMOT-15) Questionnaire in German, French and Spanish
Time frame: At enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christiane D'hondt study director
Cochlear
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Otitis Media, run by Cochlear at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and Type of Contacts With Health Care Providers (time frame: From primary tympanoplasty to time of enrolment, up to 13 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.