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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05009784
Other study ID # COT-V4-2020-1-S001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 25, 2021
Est. completion date June 15, 2023

Study information

Verified date March 2023
Source Nanyang Technological University
Contact Kar Fye Alvin Lee, PhD
Phone +6591557981
Email alvin.lee@ntu.edu.sg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Based on the Attention Restoration Theory (Kaplan, 1995), we 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, affect, cognition, and behaviour) 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. A cognitive task will be administered at the beginning of the experiment to induce fatigue to examine the restorative effects of natural sounds.


Recruitment information / eligibility

Status Recruiting
Enrollment 162
Est. completion date June 15, 2023
Est. primary completion date May 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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

Study Design


Intervention

Other:
Baseline
5-min urban park video clip (Presented on a TV)
Fatigue Manipulation
20-min 2-back task (Presented on a computer)
Traffic Sound
Active Comparator: Traffic Sound (Played through speakers)
Traffic and Masking Sound
Experimental: Traffic and Masking Sound (Played through speakers)
Silence
No Intervention: No sound (Played through speakers)

Locations

Country Name City State
Singapore Cultural Science Innovations, Nanyang Technological University Singapore

Sponsors (4)

Lead Sponsor Collaborator
Nanyang Technological University Housing and Development Board, Singapore, Ministry of National Development, Singapore, National Research Foundation, Singapore

Country where clinical trial is conducted

Singapore, 

References & 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. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary Reverse Corsi Task (Change) Change in Span up to 1 hour before and after sound intervention
Primary Reverse Corsi Task (Change) Change in Reaction Time up to 1 hour before and after sound intervention
Primary Go/NoGo Task (Change) Change in Accuracy up to 1 hour before and after sound intervention
Primary Go/NoGo Task (Change) Change in Reaction Time up to 1 hour before and after sound Intervention
Primary Electrocardiograph (Change) Change in Heart Rate Variability up to 1 hour before and after sound intervention
Primary Electrodermal Activity (Change) Change in Skin Conductance Level up to 1 hour before and after sound intervention
Primary Electrodermal Activity (Change) Change in Skin Conductance Response up to 1 hour before and after sound intervention
Primary Positive and Negative Affect Schedule - Expanded Form (Change) Change in Positive Affect Score up to 1 hour before and after sound intervention
Primary Positive and Negative Affect Schedule - Expanded Form (Change) Change in Negative Affect Score up to 1 hour before and after sound intervention
Primary Fatigue State Questionnaire (Change) Change in Fatigue State Questionnaire Score up to 1 hour before and after sound intervention
Secondary Perceived Restorativeness Soundscape Scale Perceived Restorativeness Soundscape Scale Score up to 1 hour after sound Intervention
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