NCT05679869

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 5, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

December 6, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

September 5, 2022

Last Update Submit

January 10, 2023

Conditions

Cognitive FatigueMental FatigueBehavioral PerformanceHeart Rate VariabilityWorking Memory

Outcome Measures

Primary Outcomes (2)

  • Change in Heart Rate Variability

    Electrocardiograph (Change)

    1 day (during fatiguing task and sound intervention)

  • Change in Fatigue State Questionnaire

    Change in Fatigue State Questionnaire Score

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

Study Arms (2)

VR Simulated Outdoor Environment

ACTIVE COMPARATOR

Exposure to recorded outdoor environmental sounds

Other: No masking sound

VR Simulated Outdoor Environment with Masking Sounds

EXPERIMENTAL

Exposure to recorded outdoor environmental sounds augmented with masking sounds

Other: Masking Sound

Interventions

Masking SoundOTHER

Prerecorded environmental noise and masking sounds played from headphones

VR Simulated Outdoor Environment with Masking Sounds
No masking soundOTHER

Prerecorded environmental noise but no masking sounds played from headphones

VR Simulated Outdoor Environment

Eligibility Criteria

Age18 Years - 35 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Singapore-based
  • Non-clinical
  • years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cultural Science Innovations, Nanyang Technological University

Singapore, 639798, Singapore

RECRUITING

MeSH Terms

Conditions

Mental Fatigue

Condition Hierarchy (Ancestors)

FatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Central Study Contacts

Kar Fye Alvin Lee, PhD

CONTACT

+6591557981alvin.lee@ntu.edu.sg

GEORGIOS CHRISTOPOULOS, PhD

CONTACT

+6594898379georchris7@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 5, 2022

First Posted

January 11, 2023

Study Start

December 6, 2022

Primary Completion

March 15, 2023

Study Completion

May 15, 2023

Last Updated

January 11, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)