CClinicalTrials.gg
Not yet recruitingNCT06362213DSLUpdated Apr 12, 2024

Gaining Insight Into Dual Sensory Loss

An observational study in Dual Sensory Impairment of Vision and Hearing, sponsored by Amsterdam UMC, location VUmc. Not yet recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-12.

Sponsored by Amsterdam UMC, location VUmc · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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.

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
02

Conditions studied

  • 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
03

In context

Lead sponsor

Amsterdam UMC, location VUmc is the lead sponsor of 302 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

  • Impaired cognitive functioning
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
300 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

  2. 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?

    Time frame: 1 day

  3. 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.

    Time frame: 1 day

  4. 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.

    Time frame: 1 day

07

Study locations

1 site
  • Amsterdam UMC, location VUmc
    Amsterdam, Noord Holland 1081 HV, Netherlands
08

References and documents

Individual participant data

Plan to share: Undecided — IPD cannot be shared if it includes identifiable information.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06362213
Lead sponsor
Amsterdam UMC, location VUmc
Collaborators
Royal Dutch Visio
Responsible party
R.M.A. (Ruth) van Nispen (prof.dr. R.M.A. van Nispen, Amsterdam UMC, location VUmc) — Principal investigator
First posted
Apr 12, 2024
Start date
Apr 15, 2024 (estimated)
Primary completion
Apr 2025 (estimated)
Completion
Apr 2025 (estimated)
Last update
Apr 12, 2024

Study contacts

Esther Veenman, MSc
Contact
e.veenman1@amsterdamumc.nl
+31204440105
Ruth MA van Nispen, prof.dr.
Contact
r.vannispen@amsterdamumc.nl
+31204444795
Ruth MA van Nispen, prof.dr.
principal investigator · Amsterdam UMC, location VUmc

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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