NCT06932978

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2025

Completed
12 months until next milestone

Results Posted

Study results publicly available

April 13, 2026

Completed
Last Updated

April 13, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

April 10, 2025

Results QC Date

January 29, 2026

Last Update Submit

March 24, 2026

Conditions

Keywords

Environmental controlsSmart glassesActivities of daily livingself-help deviceswearable technology

Outcome Measures

Primary Outcomes (1)

  • Change in Quest Device Score From Baseline to Post-intervention

    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

Study Arms (1)

Smart glasses

EXPERIMENTAL

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.

Device: Provision of smart glasses for environmental control use

Interventions

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.

Smart glasses

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Current environmental control system or communication aid is not compatible with smart glasses display.
  • Rapidly deteriorating condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SMART Centre, Astley Ainslie Hospital

Edinburgh, EH9 2HL, United Kingdom

Location

MeSH Terms

Conditions

Nervous System Diseases

Limitations and Caveats

Only four participants took part in this study, which may limit the generalisability of the findings to wider populations or to individuals with other neurological conditions. In addition, the researcher who conducted the interviews was also one of the clinicians involved in providing environmental control services to participants. This may introduce the possibility of response bias. These factors represent limitations of the study design and should be considered when interpreting the results.

Results Point of Contact

Title
Dr Graham Henderson
Organization
NHS Lothian

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Investigator

Study Record Dates

First Submitted

April 10, 2025

First Posted

April 17, 2025

Study Start

May 1, 2024

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

April 13, 2026

Results First Posted

April 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Not required. A summary of the data in an anonymised form is sufficient.

Locations