- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06932978
The Use of Smart Glasses for Environmental Controls
The Impact of Smart Glasses on the Usability and Satisfaction of Operating an Environmental Control System or Communication Aid
Environmental control systems are a type of assistive technology that can be controlled by a wide variety of different methods (e.g. switches) and can assist people with physical disabilities to control various electronic devices in the home. Communication aids are designed to assist people who have difficulties speaking to communicate. Both systems are designed to provide independence and potentially could have a positive effect on quality of life.
The majority of communication aid and environmental control systems aimed at high end users require a screen to be mounted in front of the user. The limitations with this are that the user is only able to access their device when it has been suitably mounted in front of them. There are occasions when mounting devices in front of the user is difficult due to other considerations for example transfers in and out of a wheelchair. As smart glasses can potentially be worn at all times during the day this could provide an effective alternative solution.
The purpose of this study is to explore with service users the usability and satisfaction provided by smart glasses when operating a communication aid/environmental control system. The study will achieve the above aim by undertaking a satisfaction questionnaire prior and post a 3 week trial of using smart glasses with their device. In addition an interview will be carried out with participants to explore the impact that smart glasses has had on the usability of their device.
Participants will be recruited by contacting eligible patients of the NHS Lothian Environmental Control Service and communication aid service. The end point of the study will be 8 months from the start date (allowing for follow up data to be collected for anyone recruited towards the end of the 6-month recruitment period).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Edinburgh, United Kingdom, EH9 2HL
- SMART Centre, Astley Ainslie Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Existing environmental control system user (age 18-80).
- Neurological condition.
- Cognitive ability to answer the questions and to give consent.
- Current environmental control system is compatible with smart glasses display.
Exclusion Criteria:
- Current environmental control system or communication aid is not compatible with smart glasses display.
- Rapidly deteriorating condition
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Smart glasses
The participant will be provided with a set of smart glasses (X-REAL Air 2) as an alternative display for their existing environmental control system.
They will have the smart glasses to trial for a period of 3 weeks.
|
To the authors knowledge there has not been a clinical trial that includes the use of smart glasses with environmental controls.
The smart glasses were used with environmental control systems that had a USB-C display output.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Quest Device Score From Baseline to Post-intervention
Time Frame: Baseline to 3 weeks
|
The QUEST 2.0 is a 12-item instrument that measures user satisfaction with assistive technology devices and related services.
Each item is scored from 1 to 5, where 1 indicates the lowest satisfaction and 5 indicates the highest satisfaction.
The instrument includes 8 device items and 4 service items.
In this study, only the 8 device items were administered because the focus was on the assistive technology device itself.
The QUEST Device Score was calculated as the mean of the 8 device item scores, producing a possible total score range from 1.0 (lowest satisfaction) to 5.0 (highest satisfaction).
The outcome represents the change in QUEST Device Score, defined as the difference between baseline and the score obtained at the end of the 3-week smart-glasses trial.
|
Baseline to 3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Semi-structured interview
Time Frame: 3 weeks after provision of smart glasses
|
The semi-structured interviews were conducted using six open-ended questions.
The questions posed included ones relating to both satisfaction and usability.
This included ones about the advantages, disadvantages and any points for improvement for the smart glasses.
Additional questions included ones about making comparisons to using a traditional screen setup, how easy or hard the smart glasses were to use and whether participants would continue to use the smart glasses.
When appropriate follow up questions were asked to elicit more information about answers.
|
3 weeks after provision of smart glasses
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AC24008
- 24/NW/0057 (Other Identifier: North West - Greater Manchester East Research Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neurologic Disorder
-
Abant Izzet Baysal UniversityNot yet recruiting
-
Fondation Ellen PoidatzRecruiting
-
Chung-Ang University Gwangmyeong HospitalNot yet recruitingNeurologic Disorder
-
Medical University of ViennaNeurologisches Rehabiliationszentrum RosenhügelRecruitingNeurologic DisorderAustria
-
Rehabilitation Hospital of Overland ParkDiscovery StatisticsRecruitingNeurologic DisorderUnited States
-
Wake Forest University Health SciencesIndiana University; Norton Healthcare; Child Neurology FoundationCompletedNeurologic DisorderUnited States
-
University Hospital, ToulouseIpsenCompleted
-
Henri Mondor University HospitalNot yet recruiting
-
Pôle Saint HélierINSA RennesCompleted
-
Tribhuvan University Teaching Hospital, Institute...Completed
Clinical Trials on Provision of smart glasses for environmental control use
-
NHS LothianCompleted
-
Centre Hospitalier Universitaire, AmiensRecruitingSleep | Newborn | Chemical Pollutants ExposureFrance
-
University of WashingtonKenyatta National Hospital; Fogarty International Center of the National Institute...CompletedPrEP Uptake | HIV Antibody PositivityKenya
-
University of Colorado, DenverChildren's Hospital ColoradoActive, not recruitingPain, Postoperative | Pectus ExcavatumUnited States
-
Linkoeping UniversityThe Swedish Research Council; the Swedish Research Council for Health, Working...RecruitingAdherence | Injury Prevention in SportsSweden
-
Infirmerie Protestante de LyonRecruitingCoronary Artery Bypass | Coronary Artery Disease(CAD) | Off Pump Coronary Artery Bypass Surgery | Hemodynamic Optimization | Hemodynamic Management | Off Pump Coronary Artery Bypass Graft | Coronary Artery Disease With Need for Bypass Surgery | NoradrenalineFrance
-
HIV Prevention Trials NetworkNational Institute of Allergy and Infectious Diseases (NIAID); Division of...CompletedHIV Infection | Sexually Transmitted Infections | Pre-exposure Prophylaxis | Systems NavigationMalawi
-
University of California, San FranciscoNational Cancer Institute (NCI); Food and Drug Administration (FDA)CompletedAdverse Effect of Other Agents Primarily Affecting the Cardiovascular System, Initial EncounterUnited States
-
Restem, LLC.CompletedCovid19 | Corona Virus Infection | ARDS | SARS-CoV Infection | CoronavirusUnited States