Ignite Creation Date:
2025-12-18 @ 9:48 AM
Ignite Modification Date:
2025-12-23 @ 6:36 PM
Study NCT ID:
NCT06362213
Status:
None
Last Update Posted:
2024-04-12 00:00:00
First Post:
2024-04-08 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gaining Insight Into Dual Sensory Loss
Sponsor:
None
Organization:
Study Overview
Official Title:
Gaining Insight Into Dual Sensory Loss: Quantitative Study
Status:
None
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DSL
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: