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Effects of Natural Sounds on Attention Restoration in Virtual Reality (VEARS)

Primary Purpose

Cognitive Fatigue, Mental Fatigue, Behavioral Performance

Status

Recruiting

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

Masking Sound

No masking sound

About this trial

This is an interventional treatment trial for Cognitive Fatigue

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Singapore-based Non-clinical 18-35years Exclusion Criteria: Individuals with hearing difficulties or failing to meet the minimal threshold for normal hearing Individuals with a history of ear, developmental, neurological, or psychiatric disorder

Sites / Locations

Cultural Science Innovations, Nanyang Technological UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

VR Simulated Outdoor Environment

VR Simulated Outdoor Environment with Masking Sounds

Arm Description

Exposure to recorded outdoor environmental sounds

Exposure to recorded outdoor environmental sounds augmented with masking sounds

Outcomes

Primary Outcome Measures

Change in Heart Rate Variability

Electrocardiograph (Change)

Change in Fatigue State Questionnaire

Change in Fatigue State Questionnaire Score

Secondary Outcome Measures

Full Information

NCT ID

NCT05679869

First Posted

September 5, 2022

Last Updated

January 10, 2023

Sponsor

Nanyang Technological University

Collaborators

National Research Foundation, Singapore, Ministry of National Development, Singapore, Housing and Development Board, Singapore

1. Study Identification

Unique Protocol Identification Number

NCT05679869

Brief Title

Effects of Natural Sounds on Attention Restoration in Virtual Reality

Acronym

VEARS

Official Title

Effects of Natural Sounds on Attention Restoration in Virtual Reality

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 6, 2022 (Actual)

Primary Completion Date

March 15, 2023 (Anticipated)

Study Completion Date

May 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nanyang Technological University

Collaborators

National Research Foundation, Singapore, Ministry of National Development, Singapore, Housing and Development Board, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study aims to examine whether listening to natural sounds in a noisy virtual reality environment compared to no natural sounds influences physiological markers.

Detailed Description

The investigators hypothesize that listening to natural sounds has restorative effects on attention by supporting greater use of involuntary attention. This generates the prediction that exposure to natural sounds in the context of a noisy environment will have greater restorative effects on attention (i.e., physiological) as compared to the control group (exposed to noise only). Individual differences (i.e., age, gender, caffeine and food intake, body mass index, skin temperature, noise sensitivity, sleep quality, baseline physiology and behavioural performance) will be examined and accounted for.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cognitive Fatigue, Mental Fatigue, Behavioral Performance, Heart Rate Variability, Working Memory

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

VR Simulated Outdoor Environment

Arm Type

Active Comparator

Arm Description

Exposure to recorded outdoor environmental sounds

Arm Title

VR Simulated Outdoor Environment with Masking Sounds

Arm Type

Experimental

Arm Description

Exposure to recorded outdoor environmental sounds augmented with masking sounds

Intervention Type

Other

Intervention Name(s)

Masking Sound

Intervention Description

Prerecorded environmental noise and masking sounds played from headphones

Intervention Type

Other

Intervention Name(s)

No masking sound

Intervention Description

Prerecorded environmental noise but no masking sounds played from headphones

Primary Outcome Measure Information:

Title

Change in Heart Rate Variability

Description

Electrocardiograph (Change)

Time Frame

1 day (during fatiguing task and sound intervention)

Title

Change in Fatigue State Questionnaire

Description

Change in Fatigue State Questionnaire Score

Time Frame

baseline, up to 2 mins after fatiguing task and up to 2 mins after sound intervention

10. Eligibility

Sex

All

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kar Fye Alvin Lee, PhD

Phone

+6591557981

alvin.lee@ntu.edu.sg

First Name & Middle Initial & Last Name or Official Title & Degree

GEORGIOS CHRISTOPOULOS, PhD

Phone

+6594898379

georchris7@gmail.com

Facility Information:

Facility Name

Cultural Science Innovations, Nanyang Technological University

City

Singapore

ZIP/Postal Code

639798

Country

Singapore

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elliot Chan, B.A.

Phone

+6596799914

elliotchan@ntu.edu.sg

12. IPD Sharing Statement

Plan to Share IPD

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Effects of Natural Sounds on Attention Restoration in Virtual Reality

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