Gaining Insight Into Dual Sensory Loss (DSL)

Gaining Insight Into Dual Sensory Loss: Quantitative Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dual Sensory Impairment of Vision and Hearing

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

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Esther Veenman, MSc; Phone Number: +31204440105; Email: e.veenman1@amsterdamumc.nl
• Study Contact Backup: Name: Ruth MA van Nispen, prof.dr.; Phone Number: +31204444795; Email: r.vannispen@amsterdamumc.nl

Study Locations

• Netherlands
  • Noord Holland
    • Amsterdam, Noord Holland, Netherlands, 1081 HV
      • Amsterdam UMC, location VUmc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
participants with dual sensory loss; participants with both vision and hearing loss
participants with vision loss; participants with vision loss only
participants with hearing loss; participants with hearing loss only
participants with normal vision and hearing; participants without vision or hearing loss

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Collaborators: Royal Dutch Visio
• Investigators: Principal Investigator: Ruth MA van Nispen, prof.dr., Amsterdam UMC, location VUmc

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: fatigue; communication; mobility; visual field; visual acuity; contrast sensitivity; information access; hearing threshold; speech understanding in noise; speech understanding in silence; directional hearing
• Other Study ID Numbers: NL76924.029.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD cannot be shared if it includes identifiable information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No