ICF in Cochlear Implant Users

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Implementation of the International Classification of Functioning, Disability and Health Model in Cochlear Implant Recipients: a Multi-center Prospective Follow-up Cohort Study

ClinicalTrials.gov ID

NCT04611555

Acronym / sponsor ID

B3002020000137

Conditions

Hearing Loss

Keywords

Cochlear Implantation, International Classification of Functioning, Disability and Health

Study type

Observational

Recruitment status

Unknown status

Enrolment

100 participants (estimated)

Lead sponsor

University Hospital, AntwerpUniversity, hospital or other

Collaborators

World Hearing Centre, Hospital Universitario La Paz, Fiona Stanley Hospital, Wuerzburg University Hospital

Study start

31 Aug 2020 (actual)

Primary completion

Jun 2022 (estimated)

Study completion

Jun 2022 (estimated)

First posted

2 Nov 2020 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Target follow-up

8 Months

Number of arms

1

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Accepted

Age groups

Adult, Older adult

Study population

Adult subjects (≥18 years old) eligible for cochlear implantation, considering the local criteria of reimbursement.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

1. Change in Work Rehabilitation Questionnaire (WORQ)

   Time frame: One month preoperatively and six months post the activation of the speech processor

   The WORQ was divided into two sections. Section one contains 18 sociodemographic and work-related questions regarding the four environmental categories from the brief ICF Core Set. The six categories from activities and participation that describe vocational education or work situations namely were also included in section one. In the main section of WORQ, 36 questions were phrased representing 34 categories. The WORQ has been revised to match the core needs of the cochlear implant ICF codes. The revised version includes 4 items in the first section and 14 items in the main section, taking less than 5 minutes to complete.

2. Change in Abbreviated Profile of Hearing Aid Benefit (APHAB)

   Time frame: One month preoperatively and six months post the activation of the speech processor

   The APHAB is a 24-item questionnaire derived from the original 66-item Profile of Hearing Aid Benefit. The self-assessment instrument evaluates hearing impairment in real-life situations with and without hearing aids. Participants have to rate how often a given statement is true in their daily life, based on the following seven response alternatives: always (99%), almost always (87%), generally (75%), half-the-time (50%), occasionally (25%), seldom (12%) and never (1%). Ease of communication, reverberation, background noise and aversiveness of sounds make up the four subscales of APHAB. In the first three subscales, higher scores suggest less hearing disability, while lower scores indicate less hearing disability in the aversiveness subscale. The APHAB typically requires 10 minutes or less to complete.

3. Change in the Audio Processor Satisfaction Questionnaire (APSQ)

   Time frame: One month preoperatively and six months post the activation of the speech processor

   The APSQ is a general questionnaire which is designed to assess the handling hearing devices, taking 5 minutes to complete. It assesses the wearing comfort, sound quality, and other device-specific factors related to the audio processor with 15 items on a VAS scale from 0 ('does not agree at all') to 10 ('fully agrees'). If an item does not apply to the subject, then the subject can tick the 'not applicable' option. The maximum number of incomplete answers for the validation analyses is set at three items per subject; if this number exceeds, then the subject shall be excluded. Hence, if participants do not wear at least one hearing device preoperatively, they will only complete in the questionnaire 6 months postactivation.

4. Change in the Speech, Spatial, and Qualities of Hearing Questionnaire with 12 items (SSQ12)

   Time frame: One month preoperatively and six months post the activation of the speech processor

   The SSQ12 is designed to measure self-reported auditory disability across a wide variety of domains, reflecting the reality of hearing in the everyday world. It takes approximately 5 minutes to complete and it covers: hearing speech in a variety of competing contexts, the directional, distance, and movement components of spatial hearing, segregation of sounds and attending to simultaneous speech streams, ease of listening, the naturalness, clarity, and identifiability of different speakers, different musical pieces and instruments, and different everyday sounds. The SSQ12 consists of 12 questions that the subjects score on a scale from 0 (not at all) to 10 (perfectly). The total score is the sum of all items and can range between 0 and 120.

5. Change in the Hearing Implant Sound Quality Index 19 (HISQUI19)

   Time frame: One month preoperatively and six months post the activation of the speech processor

   The HISQUI19 is a self-administered questionnaire to quantify the individual perceived sound quality of hearing implanted patients in daily life. The questionnaire consists of 19 seven-level Likert items ranging from "always (99%)" to "never (1%)", taking approximately 10 minutes to complete. Added percentage values support the answering. The total score is the sum of all items and ranges from 19 to 133 points. Missing data and the answer option ´not applicable' (N/A) are treated as ´missing values'. The maximum number of incomplete answers are set at three items per subject; if this number exceeds the subject shall be excluded.

6. Change in Pure tone audiometry

   Time frame: One month preoperatively and six months post the activation of the speech processor

   Pure tone audiometry will be performed according to current clinical standards (ISO 8253-1, 2010) by an experienced Good Clinical Practice (GCP) certificated audiologist (Master of science). Pre- and postoperatively, best-aided pure tone audiometry will be measured at 500, 1000, 2000, 4000 and 8000 Hz using warble tones in sound field in a sound treated booth. The loudspeaker will be placed in front of the participant at ear level at 1 meter distance. The best-aided pure tone average (PTA4) will be calculated by averaging participants' hearing thresholds at 500, 1000, 2000 and 4000 Hz in best-aided condition.

7. Change in Speech intelligibility

   Time frame: One month preoperatively and six months post the activation of the speech processor

   Speech intelligibility will be evaluated in quiet, using disyllables in Spanish and monosyllables in the other languages, and in noise, using sentences. These tests will be performed pre- and postoperatively in best-aided situation according to current clinical standards (ISO 8253-1, 2010). Participants will be sitting in front of the loudspeaker, positioned at ear level, at a one-meter distance. They will be instructed to repeat the speech stimuli they hear. Speech materials and assessment methods are aligned across the different centers cooperating in this study to obtain comparable results.

8. Change in Sound localization

   Time frame: One month preoperatively and six months post the activation of the speech processor

   Each center will use its own particular localization set-up. Centers not disposing of an appropriate set-up will only use the SSQ12 spatial subscale. The other centers use both the subjective SSQ12 and the objective localization test.

Results and safety

Results are not available in the source record.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
• Derived from this study: PubMed 40456899Andries E, Lorens A, Skarzynski PH, Skarzynski H, Calvino M, Gavilan J, Lassaletta L, Tavora-Vieira D, Acharya A, Kurz A, Hagen R, Anderson I, Koinig K, Abdelsamad Y, Van de Heyning P, Van Rompaey V, Mertens G. Impact of cochlear implant indications on outcome, assessed and reported using the international classification of functioning, disability and health model. Eur Arch Otorhinolaryngol. 2025 Oct;282(10):5153-5167. doi: 10.1007/s00405-025-09454-1. Epub 2025 Jun 3.

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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.

5 sites in 5 countries: see every site and its status.