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Effects of Natural Sounds on Attention Restoration Outdoors (NEO)

Primary Purpose

Cognitive Fatigue, Mental Fatigue, Behavioral Performance

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Masking Sounds
No Masking Sounds
Sponsored by
Nanyang Technological University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

Outdoor Environment

Outdoor Environment with Machine-Learning Selected Masking Sounds

Arm Description

Exposure to outdoor environmental noise

Exposure to outdoor environmental noise and masking sounds

Outcomes

Primary Outcome Measures

Reverse Corsi Task (Change)
Change in Span and Reaction Time
Go/NoGo Task (Change)
Change in Accuracy and Reaction Time
Change in Heart Rate Variability
Electrocardiograph and photoplethysmograph (Change)
Positive and Negative Affect Schedule - Expanded Form
Positive and Negative Affect Score
Fatigue State Questionnaire (Change)
Change in Fatigue State Questionnaire Score

Secondary Outcome Measures

Perceived Restorativeness Soundscape Scale
Perceived Restorativeness Soundscape Scale Score

Full Information

First Posted
September 5, 2022
Last Updated
March 21, 2023
Sponsor
Nanyang Technological University
Collaborators
National Research Foundation, Singapore, Ministry of National Development, Singapore, Housing and Development Board, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT05679882
Brief Title
Effects of Natural Sounds on Attention Restoration Outdoors
Acronym
NEO
Official Title
Effects of Natural Sounds on Attention Restoration Outdoors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to examine whether listening to natural sounds in a noisy outdoor environment compared to no natural sounds influences behavioural, cognitive, affective, and 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 outdoor environment will have greater restorative effects on attention (i.e., physiological, affective, cognitive, and behavioural) as compared to the control group (exposed to environmental 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. Environmental factors (i.e., outdoor humidity, temperature, and noise) will also be 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, Positive and Negative Affect, Inhibition, Psychological, Working Memory, Perceived Restoration

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
Outdoor Environment
Arm Type
Active Comparator
Arm Description
Exposure to outdoor environmental noise
Arm Title
Outdoor Environment with Machine-Learning Selected Masking Sounds
Arm Type
Experimental
Arm Description
Exposure to outdoor environmental noise and masking sounds
Intervention Type
Other
Intervention Name(s)
Masking Sounds
Intervention Description
Masking sounds will be played from outdoor speakers.
Intervention Type
Other
Intervention Name(s)
No Masking Sounds
Intervention Description
No masking sounds will be played from outdoor speakers.
Primary Outcome Measure Information:
Title
Reverse Corsi Task (Change)
Description
Change in Span and Reaction Time
Time Frame
baseline and up to 60 mins after sound intervention
Title
Go/NoGo Task (Change)
Description
Change in Accuracy and Reaction Time
Time Frame
baseline and up to 60 mins after sound intervention
Title
Change in Heart Rate Variability
Description
Electrocardiograph and photoplethysmograph (Change)
Time Frame
1 day (during fatiguing task and sound intervention)
Title
Positive and Negative Affect Schedule - Expanded Form
Description
Positive and Negative Affect Score
Time Frame
up to 60 mins after sound intervention
Title
Fatigue State Questionnaire (Change)
Description
Change in Fatigue State Questionnaire Score
Time Frame
baseline and up to 60 mins after sound intervention
Secondary Outcome Measure Information:
Title
Perceived Restorativeness Soundscape Scale
Description
Perceived Restorativeness Soundscape Scale Score
Time Frame
up to 60 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
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kar Fye Alvin Lee, PhD
Phone
+6591557981
Email
alvin.lee@ntu.edu.sg
First Name & Middle Initial & Last Name or Official Title & Degree
GEORGIOS CHRISTOPOULOS, PhD
Phone
+6594898379
Email
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
Email
elliotchan@ntu.edu.sg

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Natural Sounds on Attention Restoration Outdoors

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