NCT05009784

Brief Summary

This study aims to examine whether listening to natural sounds in a noisy (traffic) environment compared to traffic noise only impacts behavioural, cognitive, affective, and physiological markers associated with attention restoration. Attention restoration will be examined as an aspect of cognitive fatigue.

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
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration 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

August 10, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

August 25, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

1.7 years

First QC Date

August 10, 2021

Last Update Submit

March 21, 2023

Conditions

Outcome Measures

Primary Outcomes (10)

  • Reverse Corsi Task (Change)

    Change in Span

    up to 1 hour before and after sound intervention

  • Reverse Corsi Task (Change)

    Change in Reaction Time

    up to 1 hour before and after sound intervention

  • Go/NoGo Task (Change)

    Change in Accuracy

    up to 1 hour before and after sound intervention

  • Go/NoGo Task (Change)

    Change in Reaction Time

    up to 1 hour before and after sound Intervention

  • Electrocardiograph (Change)

    Change in Heart Rate Variability

    up to 1 hour before and after sound intervention

  • Electrodermal Activity (Change)

    Change in Skin Conductance Level

    up to 1 hour before and after sound intervention

  • Electrodermal Activity (Change)

    Change in Skin Conductance Response

    up to 1 hour before and after sound intervention

  • Positive and Negative Affect Schedule - Expanded Form (Change)

    Change in Positive Affect Score

    up to 1 hour before and after sound intervention

  • Positive and Negative Affect Schedule - Expanded Form (Change)

    Change in Negative Affect Score

    up to 1 hour before and after sound intervention

  • Fatigue State Questionnaire (Change)

    Change in Fatigue State Questionnaire Score

    up to 1 hour before and after sound intervention

Secondary Outcomes (1)

  • Perceived Restorativeness Soundscape Scale

    up to 1 hour after sound Intervention

Study Arms (3)

Traffic Sound

ACTIVE COMPARATOR

600 seconds of traffic sound

Other: BaselineOther: Fatigue ManipulationOther: Traffic Sound

Traffic and Masking Sounds

EXPERIMENTAL

600 seconds of traffic and masking sound

Other: BaselineOther: Fatigue ManipulationOther: Traffic and Masking Sound

Silence

ACTIVE COMPARATOR

600 seconds of no sound

Other: BaselineOther: Fatigue ManipulationOther: Silence

Interventions

5-min urban park video clip (Presented on a TV)

SilenceTraffic SoundTraffic and Masking Sounds

20-min 2-back task (Presented on a computer)

SilenceTraffic SoundTraffic and Masking Sounds

Active Comparator: Traffic Sound (Played through speakers)

Traffic Sound

Experimental: Traffic and Masking Sound (Played through speakers)

Traffic and Masking Sounds
SilenceOTHER

No Intervention: No sound (Played through speakers)

Silence

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

Related Publications (2)

  • Alvarsson JJ, Wiens S, Nilsson ME. Stress recovery during exposure to nature sound and environmental noise. Int J Environ Res Public Health. 2010 Mar;7(3):1036-46. doi: 10.3390/ijerph7031036. Epub 2010 Mar 11.

    PMID: 20617017BACKGROUND
  • Kaplan S. The restorative benefits of nature: Toward an integrative framework. J. Environ. Psychol. 1995; 15(3): 169-182.

    BACKGROUND

MeSH Terms

Conditions

Mental FatigueInhibition, Psychological

Interventions

BaseLine dental cementSIR1 protein, S cerevisiae

Condition Hierarchy (Ancestors)

FatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Central Study Contacts

Kar Fye Alvin Lee, PhD

CONTACT

GEORGIOS CHRISTOPOULOS, PhD

CONTACT

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

August 10, 2021

First Posted

August 18, 2021

Study Start

August 25, 2021

Primary Completion

May 15, 2023

Study Completion

June 15, 2023

Last Updated

March 23, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations