Feasibility Study of Virtual Sail 3D in Cognitive Functions

NCT06579378 | Recruiting

• 1 other identifier: NP/2023/2557
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This research project will assess the feasibility and preliminary effectiveness of a 6-week intervention to improve cognitive functions using the 3D immersive virtual reality software "CEREBRUM" with virtual sailing scenarios among elderly with mild cognitive impairment. CEREBRUM, developed by PRoMIND in association with IDEGO, is the first European tool for enhancing cognitive functions via 3D immersive virtual reality in psychosocial disabilities. Previous studies have shown its effectiveness in improving cognitive functions and well-being in people with bipolar disorders. The software includes modules for memory, learning, cognitive estimations, attention, working memory, and executive functions. For this study, the software was developed with sailing virtual scenarios to make it more enjoyable and engaging, as well as to train other cognitive functions such as motor skills and language abilities among people with disabilities.

Conditions

Mild Cognitive Impairment

Keywords

Virtual reality; Feasibility; Cognitive functions; Sail; Advances Technologies Laboratory

Outcome Measures

Primary Outcomes (3)

• Dropout rates; Proportion of recruited participants among those considered eligible;

  Feasibility will be assessed based on tolerability, including dropout rates and acceptability, which considers the proportion of recruited participants among those considered eligible.

  T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)

• Simulator Sickness Questionnaire (SSQ)

  Feasibility will be assessed based on side effects through the Simulator Sickness Questionnaire (SSQ), a self-report questionnaire that evaluates the frequency of unwanted effects that may occur due to the use of virtual reality technologies, such as nausea, dizziness, headaches, eye strain, etc. 16 items. The score range is 0-48, with higher scores indicating worse side effects.

  T0 (0 weeks) - T1 (6 weeks)

• Self-report satisfaction questionnaire

  Feasibility will be assessed based on a Self-report satisfaction questionnaire, constructed ad hoc to evaluate the level of satisfaction with the program as a whole, the effect on psychophysical health, helping and listening abilities demonstrated by the operators, organizational support for activities, satisfaction with initial expectations. The score range is 6-30, with higher scores indicating higher satisfaction.

  T1 (6 weeks)

Secondary Outcomes (8)

• Trail Making Test

  T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)

• Digit Span

  T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)

• Stroop Test

  T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)

• Rey Figure Test

  T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)

• Frontal Assessment Battery (FAB)

  T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)

Other Outcomes (9)

• Short Form Health Survey, 12 items (SF-12)

  T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)

• Patient Health Questionnaire (PHQ-9)

  T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)

• Generalized Anxiety Disorder-7 item (GAD-7)

  T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)

Study Arms (2)

VSail 3D

EXPERIMENTAL

The "VSail 3D" experimental protocol includes 12 sessions (2 times a week, for 6 consecutive weeks) with scenarios (virtual environments) dedicated to the sport of sailing. The duration of each session is 50-60 minutes.

Device: VSail 3D

WEB-Health

ACTIVE COMPARATOR

The intervention regards education on healthy lifestyles to promote active ageing (topics: physical activity in old age; effective communication, stress management, technologies and health). It will consist of 3 seminars, delivered in the form of webinars, on a bi-weekly basis over 6 consecutive weeks, lasting 50-60 minutes each.

Other: WEB-Health

Interventions

VSail 3D DEVICE

The "CEREBRUM" software with virtual sailing scenarios is made up of exercises of variable difficulty, designed to train different cognitive functions, in particular attention, memory, learning, cognitive estimates, working memory, executive functions, motor abilities and language. The different degrees of difficulty are designed to adapt to the user's functional diagnosis. The operator who conducts the intervention must adapt the difficulty level to the user's residual abilities, so that the exercises are neither too easy nor too complex. Each session, after an initial part of welcome, psychoeducation and orientation to the instrument, involves alternating virtual reality exercises, positive and corrective feedback, and suggestions of practical homework related to the cognitive function trained during the session that the individual should try during daily life.

VSail 3D

WEB-Health OTHER

The intervention includes a series of 3 webinars focused on active ageing promotion. In particular, each webinar will regard topics related to healthy lifestyle, such as physical activity in old age, effective communication, stress management, technologies and health. Each webinar will be conducted by a mental health professional, and it will be delivered in real-time in a group (plenary).

WEB-Health

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age: 65 years or older
• Sex: all
• Living independently,
• Without conditions that would prevent them from participating in the activities of the experimental intervention "VSail 3D,"
• Without severe issues with autonomous mobility
• With Mild Cognitive Impairment (MCI) according to Addenbrooke's Cognitive Examination for cognitive functions (ACE-R), which also includes the Mini-Mental State Examination (MMSE), with the following ranges: ACE = 66.93-79.86 and/or MMSE = 21-25.
• Signing the informed consent

You may not qualify if:

• severe cardiovascular conditions
• severe issues with autonomous mobility
• severe metabolic disorders not pharmacologically compensated
• severe neurological conditions that prevent from participating in the experimental protocol, such as a stroke within the past 2 years, Parkinson's disease, epilepsy, or dementia (Alzheimer's, vascular, etc.)
• severe ongoing bronchopulmonary disorders
• severe ongoing renal disorders
• glaucoma, retinal detachment, or other serious vision conditions that do not allow the safe use of 3D virtual reality technology
• active malignant neoplasm that do not allow the hinders participation in the intervention.

Sponsors & Collaborators

• University of Cagliari: lead
• Fondazione di Sardegna: collaborator

Study Sites (1)

University Hospital of Cagliari

Cagliari, CA, 09124, Italy

RECRUITING

Related Publications (1)

• Sancassiani F, Perra A, Vacca V, Montisci R, Monni M, Lorrai S, Cossu G, Petretto DR, di Natale L, Primavera D, Redolfi S, Scuteri A, Nardi AE, Kalcev G, Pau M, Carta MG. Enhancing Cognitive Functions in Older Adults With Mild Cognitive Impairment via Virtual Sail 3D: Protocol for a Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2026 Jan 15;15:e85089. doi: 10.2196/85089.

  PMID: 41538788 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Federica Sancassiani, Prof

CONTACT

00393493119215; federicasancassiani@yahoo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 30, 2024
• Study Start: May 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 30, 2024

Record last verified: 2024-08

Locations

IT (1)