Clinical trial NCT05525221: Societal Merit of Intervention on Hearing Loss Evaluation
Official title: Societal Merit of Intervention on Hearing Loss Evaluation - Investigating the Impact of (Waiting for) Cochlear Implantation in People With Severe to Profound Sensorineural Hearing Loss on Societal Related Outcomes.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hearing Loss, Sensorineural
Hearing Loss, Bilateral
Hearing Loss, Adult-Onset
Hearing Loss, Bilateral Sensorineural, Progressive
Keywords: Cochlear Implantation
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2022-09-01
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with moderate-severe to profound hearing loss who are referred to a tertiary hospital for potentially receiving a cochlear implant.

Brief summary: The primary objective of this study is to determine the (long term) effect of intervention with a CI in adult participants with progressive postlingual moderate/severe-to-profound sensorineural hearing loss on societal related outcomes (participation; communication profile; autonomy; cognition; listening effort; work; productivity loss; income; medical consumption; third party quality of life; quality of life, and capability).

The secondary objective is to determine the effect of CI waiting time between referral and CI surgery on the same societal related outcomes, in the adults with postlingual moderate/severe-to-profound sensorineural hearing loss.

Detailed description: Cochlear implantation (CI) is a surgical intervention to improve the hearing of patients with profound hearing loss. Due to the improvements in CI-technology and knowledge regarding surgery and CI fitting, speech recognition with CI has improved over the past decades. This has led to relaxation of the audiological implantation criteria. Whereas CI was initially indicated for patients with total deafness, currently also patients with moderate/severe-to-profound hearing loss are eligible for CI.

Moderate/severe-to-profound hearing loss has a negative effect on the patients' functioning. Because often hearing loss in adults is progressive, resulting in a decline in speech recognition, the disability might progress during this waiting time to a state in which societal participation can become even more difficult: the hearing loss might affect social participation, autonomy, work/occupational status and quality of life. However empirical data on this is not yet available. Timely intervention, like cochlear implantation may prevent societal drop out.

The societal impact of cochlear implantation for patients who are (currently) eligible for CI is unknown. It is imperative to obtain this data in order to secure treatment for those who need it. This multicenter cohort observational study is set up to investigate the impact of moderate/severe-to-profound hearing loss on societal related outcomes, defined as participation; communication profile; autonomy; cognition; listening effort; work; productivity loss; income; medical consumption; third party quality of life; quality of life, and capability. The primary aim is to investigate the effect of hearing rehabilitation with cochlear implantation on these societal related outcomes.

Castoredc (Castor electronic data capture) will be used for capturing research data. Questionnaires will be constructed in castors' online survey service and administered to participants online.

IBM SPSS Statistics and R studio software will be used for the statistical analysis. Descriptive analysis will be conducted to assess the baseline characteristics and the continuous variables will be summarized with mean ± SD or median (interquartile range) (if not normally distributed) and categorical variables with percentage (numbers). The statistical analysis for the primary objective, the differences in baseline(T0) and T2/T3/T4 for the primary outcome variables, we will use general linear models with the outcome (differences) as independent variable. To investigate the complete pattern in time of the effects we will use mixed models, in which time is an additional explanatory categorical variable. For the secondary objective the effect between baseline(T0) and T1, short before CI surgery will be investigated. General linear models with the outcome (differences) as independent variable.

Eligibility criteria: Inclusion Criteria:

* Adults (potentially) eligible for CI according to the Dutch quality standard for CI (Veldnorm CI 2013) and willing to participate. Participants are divided in 2 age categories (under and over 65 years old)

Exclusion Criteria:

* People with a complex syndrome with multiple problems.
* Incapable of performing paid or unpaid labor, due to non-hearing related factors
* Prelingual onset of deafness.
* Children 0 - 18 years old.
* Non-native Dutch speakers.
* Patients suffering from a psychiatric disorder
* Any condition that may hamper a complete insertion of the electrode array or a normal rehabilitation with the cochlear implant (severe otosclerosis or neurologic deficits)

Primary outcomes:
measure: Change in Participation
timeFrame: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)
Secondary outcomes:
measure: Change in Autonomy
timeFrame: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)
measure: Change in Communication profile
timeFrame: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)
measure: Change in Work experience and status
timeFrame: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)
measure: Change in Work capabilities
timeFrame: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)
measure: Change in Productivity Costs Questionnaire
timeFrame: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)
measure: Change in Medical Consumption Questionnaire
timeFrame: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)
measure: Change in Capability
timeFrame: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)
measure: Change in Generic Quality of Life (EQ5D-5L)
timeFrame: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)
measure: Change in Generic Quality of Life (HUI-3)
timeFrame: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)
measure: Change in Third Party Hearing loss related quality of life measured by Hearing Impairment Impact-Significant Other Profile (HII-SOP).
timeFrame: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)
measure: Change in Disease specific Quality of Life measured by Nijmegen Cochlear Implant Questionnaire (NCIQ)
timeFrame: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)
measure: Change in Income (source)
timeFrame: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)
measure: Change in Cognition
timeFrame: Once between study inclusion and surgery (pre-operative), 1 year post surgery, and (if participant is over 65 years old) 2 years post surgery.
measure: Change in Listening effort
timeFrame: 4 weeks after surgery and 1 year after surgery.
measure: Change in Linguistic skills by Vocabulary test
timeFrame: Once between inclusion and surgery.
measure: Change in Tinnitus
timeFrame: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)
measure: Change in quality of life score post-intervention
timeFrame: T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)
Other outcomes:
measure: Change in Audiological outcomes Tone thresholds
timeFrame: Pre-surgery and 1 year post-surgery
measure: Change in Audiological outcomes speech perception score unaided by using NVA lists and CVC words/phonemes.
timeFrame: Pre-surgery and 1 year post-surgery
measure: Change in Audiological outcomes speech perception score aided by using NVA lists and CVC words/phonemes.
timeFrame: Pre-surgery and 1 year post-surgery
measure: Change in Audiological outcomes - speech perception score aided free field by using NVA lists and CVC words/phonemes.
timeFrame: Pre-surgery and 1 year post-surgery
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
state: Limburg
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
city: Leiden
country: Netherlands
facility: Leids UMC
state: Zuid-Holland
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: Radboud University Medical Center
name: Emmanuel Mylanus
role: STUDY_DIRECTOR
References: