NCT05583903

Brief Summary

This study aims to determine feasibility, acceptability, and usability, and to assess the safety of using a virtual reality-based software called ''ReCognitionVR'' in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

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

August 14, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
5 months until next milestone

Results Posted

Study results publicly available

November 21, 2023

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

October 7, 2022

Results QC Date

July 11, 2023

Last Update Submit

November 17, 2023

Conditions

Virtual Reality

Keywords

Young Healthy VolunteersElderly Healthy VolunteersUser-Centered DesignCognitive Exercises

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Using Virtual Reality Software at 20 Minutes After Start

    Whether 70% of participants in each group will complete 20 minutes of use of the ReCognition VR-based software (a binary outcome)

    20 minutes after the start of software use

Secondary Outcomes (14)

  • Participants With a System Usability Scale Score >35

    After completion of use of the virtual reality software, up to 2 hours after the start of software use

  • Participant High Score in Easy Mode

    After completion of use of the virtual reality software, up to 2 hours after the start of software use

  • Participant High Score in Medium Difficulty Mode

    After completion of use of the virtual reality software, up to 2 hours after the start of software use

  • Participant High Score in Hard Mode

    After completion of use of the virtual reality software, up to 2 hours after the start of software use

  • Change From Baseline in Heart Rate After 10 Minutes of Virtual Reality Software Use

    Baseline and 10 minutes

  • +9 more secondary outcomes

Study Arms (2)

Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years

EXPERIMENTAL

Healthy volunteers between the ages of 18 and 35 years will utilize the ReCognition virtual reality software

Other: Virtual Reality Software

Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years

EXPERIMENTAL

Healthy volunteers 60 years of age and older will utilize the ReCognition virtual reality software

Other: Virtual Reality Software

Interventions

Virtual Reality SoftwareOTHER

The ReCognition virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions.

Also known as: ReCognition Virtual Reality Software
Virtual Reality Software Usability in Healthy Volunteers Age 18-35 YearsVirtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years

Eligibility Criteria

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

You may qualify if:

  • Age 18-35 years or ≥60 years
  • Healthy volunteers who meet one of the following criteria according to their self-reported medical history:
  • American Society of Anesthesiologists (ASA) 1: A normal healthy patient. Example: Fit, nonobese (BMI under 30), a nonsmoking patient with good exercise tolerance.
  • ASA 2: A patient with mild systemic disease. Example: Patient with no functional limitations and a well-controlled disease (eg, treated hypertension, obesity with BMI under 35, frequent social drinker, but is nonsmoking).

You may not qualify if:

  • Age \<18 years; 36-59 years
  • Person with active psychiatric disorders, especially schizophrenia
  • Person who is deaf or blind

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location

Results Point of Contact

Title
Dr. Hina Faisal
Organization
Department of Surgery, Houston Methodist Hospital
hfaisal@houstonmethodist.org
713-714-4973

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Surgery

Study Record Dates

First Submitted

October 7, 2022

First Posted

October 18, 2022

Study Start

August 14, 2022

Primary Completion

May 31, 2023

Study Completion

June 30, 2023

Last Updated

November 21, 2023

Results First Posted

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)