Gaining Insight Into Dual Sensory Loss

NCT ID: NCT06362213

Last Updated: 2024-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-15

Study Completion Date

2025-04-30

Brief Summary

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The goal of this observational study is to explore difficulties in information access, mobility, communication and fatigue in people with combined vision and hearing impairments. The main question it aims to answer is:

• What influence do varying severities of vision and hearing loss have on information access, mobility, communication and fatigue.

Participants will fill out questionnaires and the researchers will measure their vision and hearing functions.

Detailed Description

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People with dual sensory loss have impairments in both vision and hearing. When the impairments are severe, it will become more difficult to compensate for these impairments. This can result in difficulties, for example in the areas of access to information, communication, fatigue and/or mobility. Now, we do not know which problems arise from different combinations and levels of impairments in visual acuity, contrast sensitivity, visual field, hearing threshold, directional hearing and speech understanding. We also do not know how this influences the areas of access to information, communication, fatigue and mobility.

The objective of this study is to determine which problems arise from different levels of impairments in visual and auditory functions. We will especially focus on the areas of access to information, communication, fatigue and mobility.

Study design

Participants' visual (visual acuity, visual field, contrast sensitivity) and auditory functions (hearing threshold, directional hearing, speech understanding) will be measured. We will use the following materials:

* ETDRS card
* Vistech card
* Octopus perimeter
* Affinity compact audiometer
* 8 Genelec 8020 DPM speakers (to measure directional hearing)
* Digits in Noise (DIN) test and NVA word lists

Several questionnaires will be filled out to measure difficulties in the areas of access to information, communication, fatigue and mobility:

* Dutch ICF Activity Inventory - domains watching TV, using a computer, using a telephone, mobility outdoors (walking), using public transportation and feeling fit
* Speech, Spatial and Qualities of Hearing Scale
* Spatial Localization Questionnaire
* Fatigue Assessment Scale

Study population:

* 150 people with dual sensory loss
* 50 people with a visual impairment
* 50 people with an auditory impairment
* 50 people with normal vision and hearing

Conditions

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Dual Sensory Impairment of Vision and Hearing

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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participants with dual sensory loss

participants with both vision and hearing loss

No interventions assigned to this group

participants with vision loss

participants with vision loss only

No interventions assigned to this group

participants with hearing loss

participants with hearing loss only

No interventions assigned to this group

participants with normal vision and hearing

participants without vision or hearing loss

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Older than 18 years
* Good understanding of the Dutch language
* Clients: visual and/or auditory impairment (congenital or acquired)
* Other participants: normal vision and hearing

Exclusion Criteria

* Impaired cognitive functioning
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Dutch Visio

OTHER

Sponsor Role collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role lead

Responsible Party

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R.M.A. (Ruth) van Nispen

prof.dr. R.M.A. van Nispen

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ruth MA van Nispen, prof.dr.

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

Locations

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Amsterdam UMC, location VUmc

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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Esther Veenman, MSc

Role: CONTACT

+31204440105

Ruth MA van Nispen, prof.dr.

Role: CONTACT

+31204444795

Other Identifiers

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NL76924.029.22

Identifier Type: -

Identifier Source: org_study_id

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