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

NCT04864912 | Completed Results DMC

• 1 other identifier: CBAS5780
• Study Type: observational
• Target: 69
• Locations: 3 countries
• Sites: 6

Brief 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. 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

Keywords

Primary tympanoplasty

Outcome Measures

Primary Outcomes (3)

• Number and Type of Contacts With Health Care Providers

  Contacts are obtained from medical records, counted and categorized.

  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.

  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.

  From primary tympanoplasty to time of enrolment, up to 13 years

Secondary Outcomes (9)

• Hearing Performance Assessed Via an Audiogram

  Up to 12 months prior to primary tympanoplasty

• Hearing Performance Assessed Via an Audiogram

  Within 12 months after primary tympanoplasty

• Hearing Performance Assessed Via an Audiogram

  Up to 6 years prior to study enrollment

• Health Care Costs

  From primary tympanoplasty to time of enrolment.

• Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey

  At enrolment

Interventions

Questionnaires and survey OTHER

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cochlear: lead
• QbD Clinical: collaborator
• Suministros Hospitalarios Medical Group: collaborator

Study Sites (6)

Hôpital Bicêtre, Hôpitaux universitaires Paris Sud AP-HP

Le Kremlin-Bicêtre, 94275, France

Location

ENT department - Bâtiment Pierre Paul Riquet - Hôpital Purpan

Toulouse, 31059, France

Location

Universitätsklinik für Hals-, Nasen und Ohrenheilkunde

Freiburg im Breisgau, 79106, Germany

Location

Hals-, Nasen- und Ohrenklinik, Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Hospital Universitario Donostia

Donostia / San Sebastian, 20080, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: PRS Specialist
• Organization: Cochlear

cltd-prs-admin@cochlear.com

+61 2 9428 6555

Study Officials

• Christiane D'hondt

  Cochlear

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 29, 2021
• Study Start: February 1, 2022
• Primary Completion: October 9, 2023
• Study Completion: October 9, 2023
• Last Updated: March 7, 2025
• Results First Posted: March 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); ES (2); DE (2)