Gaining Insight Into Dual Sensory Loss

Dual Sensory Impairment of Vision and Hearing Clinical Trial

— DSL  

Official title:

Gaining Insight Into Dual Sensory Loss: Quantitative Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06362213
• Other study ID #: NL76924.029.22
• Status: Not yet recruiting
• Start date: April 15, 2024
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Amsterdam UMC, location VUmc
• Contact: Esther Veenman, MSc
• Phone: +31204440105
• Email: e.veenman1[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dual Sensory Impairment of Vision and Hearing

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, location VUmc	Amsterdam	Noord Holland

Sponsors (2)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc	Royal Dutch Visio

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	information access	Access to information will be measured with the Dutch ICF Activity Inventory (subscales 'Watching TV', 'Using a computer' and 'Using a telephone'). These subscales consist of 11, 13 and 5 items, respectively (29 items in total). All items are scored on a 5-point likert scale.	1 day
Primary	mobility	Mobility will be measured with the Dutch ICF Activity Inventory (subscales 'Mobility outdoors (walking)' and 'Using public transportation'). These subscales consist of 16 and 15 items, respectively (31 items in total). All items are scored on a 5-point likert scale. Secondly, the Spatial Localization Questionnaire20 will be used, consisting of 35 items, describing common scenarios. The following question structure is provided under each of the scenarios: Can you complete this task solely with your current vision? If yes, how difficult is it? (rated on a 5-point likert scale) Can you complete this task solely with your current hearing? If yes, how difficult is it? (rated on a 5-point likert scale) Would you primarily rely on your vision or hearing for this task? Do you use the other sense for this task at all?	1 day
Primary	communication	Communication will be measured with the Speech, Spatial and Qualities of Hearing Scale (speech subscale). This subscale consists of 14 items and is scored on an 11-point visual analog scale.	1 day
Primary	fatigue	Fatigue will be measured with the Dutch ICF Activity Inventory (feeling fit subscale). This subscale consists of 9 items, scored on a 5-point likert scale. Secondly, the Fatigue Assessment Scale will be used, consisting of 10 items, scored on a 5-point likert scale.	1 day