NCT05709431

Brief Summary

The Cochlear Implant - Quality of Life (CIQoL) PROM is a quality-of-life assessment questionnaire for adults with cochlear implants. The CIQoL responds to an important need for a questionnaire that captures the benefits of cochlear implantation as perceived by patients and that can be used in clinical practice.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 2, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

October 12, 2022

Last Update Submit

January 23, 2023

Conditions

PROMCochlear Hearing LossHearing LossQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Evaluate the measurement properties of the French CIQoL-35.

    The patient is given a paper questionnaire containing the 35 items. The questionnaire indicates the following instructions: "Think about your daily life with your cochlear implant (and/or hearing aid, if you also use one). Answer how often each of the following statements applies to your feelings and experiences. Answer how often each statement applies even if you don't use cochlear implants or hearing aids."

    Day 1 (one visit planned)

Secondary Outcomes (4)

  • Speech performance in quiet

    Day 1 (one visit planned)

  • Speech performance in noise

    Day 1 (one visit planned)

  • Describe the duration of French CIQoL-35 administration

    Day 1 (one visit planned)

  • Correlation between variable of interest CIQoL score and explicative variable such as speech performance and demographics.

    Day 1 (one visit planned)

Interventions

Questionnaire CIQoL-35OTHER

The Cochlear Implant - Quality of Life (CIQoL) PROM is a quality-of-life assessment questionnaire for adults with cochlear implants (1-7). The CIQoL responds to an important need for a questionnaire that captures the benefits of cochlear implantation as perceived by patients and that can be used in clinical practice. The CIQoL is available in two lengths: 35 questions (CIQoL-35) and 10 questions (CIQoL-10). The CIQoL-35 has interesting measurement properties including good construct validity, convergent validity, and test-retest reliability.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

50 patients aged 18 years and older, with bilateral, severe-to-profound sensorineural hearing loss, with at least one cochlear implant for more than 6 months with the ability to read, understand, and indicate their answers to the 35-item French CIQoL questionnaire.

You may qualify if:

  • Adult (≥ 18 years) user of at least one cochlear implant system,
  • Duration of cochlear experience ≥ 6 months (period from cochlear implant activation to study enrolment),
  • Psychological/literacy ability to read, understand, and complete the questionnaire.

You may not qualify if:

  • Patient who participated in initial validation of the French CIQoL-35 (CIQoL project part 1),
  • Patient with a psychological or linguistic inability to understand the information sheet or the questionnaire,
  • Patient under legal protection or deprived of liberty,
  • Unwillingness or inability to comply with all investigational requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherche en Audiologie adulte

Paris, Île-de-France Region, 75013, France

RECRUITING

MeSH Terms

Conditions

Hearing Loss, SensorineuralHearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Isabelle MOSNIER

    GH Pitié-Salpêtrière, APHP Sorbonne Université, Paris, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah CHOUIKH

CONTACT

+33493951818saoh@oticonmedical.com

Michel HOEN

CONTACT

+33493951818mhoe@oticonmedical.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2022

First Posted

February 2, 2023

Study Start

January 12, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 2, 2023

Record last verified: 2023-01

Locations

FR(1)