Clinical trial NCT06362213: Gaining Insight Into Dual Sensory Loss
Official title: Gaining Insight Into Dual Sensory Loss: Quantitative Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dual Sensory Impairment of Vision and Hearing
Keywords: information access
mobility
communication
fatigue
visual acuity
contrast sensitivity
visual field
hearing threshold
speech understanding in noise
speech understanding in silence
directional hearing
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: Royal Dutch Visio
First posted: 2024-04-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with dual sensory loss have impairments in both vision and hearing, which can range from total vision and hearing loss to having limited residual vision and hearing.

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: information access
timeFrame: 1 day
measure: mobility
timeFrame: 1 day
measure: communication
timeFrame: 1 day
measure: fatigue
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location VUmc
state: Noord Holland
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Ruth MA van Nispen, prof.dr.
role: PRINCIPAL_INVESTIGATOR
References: