- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05679882
Effects of Natural Sounds on Attention Restoration Outdoors (NEO)
March 21, 2023 updated by: Georgios CHRISTOPOULOS, Nanyang Technological University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Singapore, Singapore, 639798
- Recruiting
- Cultural Science Innovations, Nanyang Technological University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Outdoor Environment
Exposure to outdoor environmental noise
|
No masking sounds will be played from outdoor speakers.
|
Experimental: Outdoor Environment with Machine-Learning Selected Masking Sounds
Exposure to outdoor environmental noise and masking sounds
|
Masking sounds will be played from outdoor speakers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reverse Corsi Task (Change)
Time Frame: baseline and up to 60 mins after sound intervention
|
Change in Span and Reaction Time
|
baseline and up to 60 mins after sound intervention
|
Go/NoGo Task (Change)
Time Frame: baseline and up to 60 mins after sound intervention
|
Change in Accuracy and Reaction Time
|
baseline and up to 60 mins after sound intervention
|
Change in Heart Rate Variability
Time Frame: 1 day (during fatiguing task and sound intervention)
|
Electrocardiograph and photoplethysmograph (Change)
|
1 day (during fatiguing task and sound intervention)
|
Positive and Negative Affect Schedule - Expanded Form
Time Frame: up to 60 mins after sound intervention
|
Positive and Negative Affect Score
|
up to 60 mins after sound intervention
|
Fatigue State Questionnaire (Change)
Time Frame: baseline and up to 60 mins after sound intervention
|
Change in Fatigue State Questionnaire Score
|
baseline and up to 60 mins after sound intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Restorativeness Soundscape Scale
Time Frame: up to 60 mins after sound intervention
|
Perceived Restorativeness Soundscape Scale Score
|
up to 60 mins after sound intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 24, 2022
Primary Completion (Anticipated)
March 15, 2023
Study Completion (Anticipated)
May 15, 2023
Study Registration Dates
First Submitted
September 5, 2022
First Submitted That Met QC Criteria
January 10, 2023
First Posted (Actual)
January 11, 2023
Study Record Updates
Last Update Posted (Actual)
March 23, 2023
Last Update Submitted That Met QC Criteria
March 21, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COT-V4-2020-1-S004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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