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临床试验/NCT06362213
NCT06362213尚未招募不适用

Gaining Insight Into Dual Sensory Loss: Quantitative Study

Amsterdam UMC, location VUmc1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
试验地点
1
主要终点
mobility

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Impaired cognitive functioning

结局指标

主要结局

mobility

时间窗: 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?

information access

时间窗: 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.

fatigue

时间窗: 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.

communication

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Amsterdam UMC, location VUmc
申办方类型
Other
责任方
Principal Investigator
主要研究者

R.M.A. (Ruth) van Nispen

prof.dr. R.M.A. van Nispen

Amsterdam UMC, location VUmc

研究点 (1)

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