Dual Sensory Impairment of Vision and HearingDSLNCT06362213
Gaining Insight Into Dual Sensory Loss
An observational study of Dual Sensory Impairment of Vision and Hearing, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dual Sensory Impairment of Vision and Hearing
- How many people
- 300 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Apr 2024to Apr 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Impaired cognitive functioning
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam UMC, location VUmc
Amsterdam, North Holland, 1081 HV
About this study
Official title: 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.
Read the 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
- Keywords
- information access, mobility, communication, fatigue, visual acuity, contrast sensitivity, visual field, hearing threshold, speech understanding in noise, speech understanding in silence, directional hearing
- Medical subject headings
- Communication, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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?
Measured: 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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start15 Apr 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dual Sensory Impairment of Vision and HearingStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Dutch Visio
- Responsible party
- Principal investigator, R.M.A. (Ruth) van Nispen, Amsterdam UMC, location VUmc
- Investigators
- Ruth MA van Nispen, prof.dr., Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362213
- Sponsor's protocol ID
- NL76924.029.22
- Acronym
- DSL
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD cannot be shared if it includes identifiable information.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gaining Insight Into Dual Sensory Loss: Quantitative Study
- ClinicalTrials.gov ID
- NCT06362213
- Acronym / sponsor ID
- DSL / NL76924.029.22
- Keywords
- information access, mobility, communication, fatigue, visual acuity, contrast sensitivity, visual field, hearing threshold
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Royal Dutch Visio
- Study start
- 15 Apr 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Impaired cognitive functioning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
information access
Time frame: 1 day
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.
mobility
Time frame: 1 day
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?
communication
Time frame: 1 day
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.
fatigue
Time frame: 1 day
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: Undecided. IPD cannot be shared if it includes identifiable information.
Related trials for Dual Sensory Impairment of Vision and Hearing
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SENSE-Brain Health Pro for Older Adults With Sensory Loss
Vision and Hearing Loss, Vision Impairment
Not yet recruitingObservational study
Survey of Sensory Impairment Indicators Among Adults Aged 65 Years and Older in Xinxing County
Visual Impairment, Hearing Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth MA van Nispen, prof.dr. principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dual Sensory Impairment of Vision and Hearing, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esther Veenman, MSc (+31204440105, e.veenman1@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
information access (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.