Cognitive FatigueNEONCT05679882
Effects of Natural Sounds on Attention Restoration Outdoors
A study testing Masking Sounds and No Masking Sounds in people with Cognitive Fatigue and Mental Fatigue, run by Nanyang Technological University at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Fatigue, Mental Fatigue, Behavioral Performance
- What is being tested?
- Masking Sounds and No Masking Sounds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- 24 Oct 2022to 15 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singapore-based
- Non-clinical
- 18-35years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Cultural Science Innovations, Nanyang Technological University
Singapore, 639798
Elliot Chan, B.A., +6596799914, elliotchan@ntu.edu.sg
About this study
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.
Read the 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.
- Conditions
- Cognitive Fatigue, Mental Fatigue, Behavioral Performance, Heart Rate Variability, Positive and Negative Affect, Inhibition, Psychological
- Being tested
- Masking Sounds, No Masking Sounds
- Medical subject headings
- Mental Fatigue, Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masking SoundsOther
Masking sounds will be played from outdoor speakers.
No Masking SoundsOther
No masking sounds will be played from outdoor speakers.
| Study group | Role | What they receive |
|---|---|---|
| Outdoor Environment | Active comparator | Exposure to outdoor environmental noise Receives: Other: No Masking Sounds |
| Outdoor Environment with Machine-Learning Selected Masking Sounds | Experimental | Exposure to outdoor environmental noise and masking sounds Receives: Other: Masking Sounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reverse Corsi Task (Change)
Change in Span and Reaction Time
Measured: baseline and up to 60 mins after sound intervention
Go/NoGo Task (Change)
Change in Accuracy and Reaction Time
Measured: baseline and up to 60 mins after sound intervention
Change in Heart Rate Variability
Electrocardiograph and photoplethysmograph (Change)
Measured: 1 day (during fatiguing task and sound intervention)
Positive and Negative Affect Schedule - Expanded Form
Positive and Negative Affect Score
Measured: up to 60 mins after sound intervention
Fatigue State Questionnaire (Change)
Change in Fatigue State Questionnaire Score
Measured: baseline and up to 60 mins after sound intervention
Secondary outcomes (1)
Perceived Restorativeness Soundscape Scale
Perceived Restorativeness Soundscape Scale Score
Measured: up to 60 mins after sound intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start24 Oct 2022
- Primary completion15 Mar 2023 (estimated)
- Study completion15 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanyang Technological University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation, Singapore, Ministry of National Development, Singapore, Housing and Development Board, Singapore
- Responsible party
- Principal investigator, Georgios CHRISTOPOULOS, Nanyang Technological University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679882
- Sponsor's protocol ID
- COT-V4-2020-1-S004
- Acronym
- NEO
- Status last verified
- Mar 2023
- First submitted
- 5 Sep 2022
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Natural Sounds on Attention Restoration Outdoors
- ClinicalTrials.gov ID
- NCT05679882
- Acronym / sponsor ID
- NEO / COT-V4-2020-1-S004
- Conditions
- Cognitive Fatigue, Mental Fatigue, Behavioral Performance, Heart Rate Variability, Positive and Negative Affect, Inhibition, Psychological
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nanyang Technological UniversityUniversity, hospital or other
- Collaborators
- National Research Foundation, Singapore, Ministry of National Development, Singapore, Housing and Development Board, Singapore
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 15 Mar 2023 (estimated)
- Study completion
- 15 May 2023 (estimated)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outdoor Environment | Active comparator | Other: No Masking SoundsExposure to outdoor environmental noise |
| Outdoor Environment with Machine-Learning Selected Masking Sounds | Experimental | Other: Masking SoundsExposure to outdoor environmental noise and masking sounds |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Singapore-based
- Non-clinical
- 18-35years
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Masking SoundsMasking sounds will be played from outdoor speakers. | Other | Outdoor Environment with Machine-Learning Selected Masking Sounds |
| No Masking SoundsNo masking sounds will be played from outdoor speakers. | Other | Outdoor Environment |
Primary outcome
Reverse Corsi Task (Change)
Time frame: baseline and up to 60 mins after sound intervention
Change in Span and Reaction Time
Go/NoGo Task (Change)
Time frame: baseline and up to 60 mins after sound intervention
Change in Accuracy and Reaction Time
Change in Heart Rate Variability
Time frame: 1 day (during fatiguing task and sound intervention)
Electrocardiograph and photoplethysmograph (Change)
Positive and Negative Affect Schedule - Expanded Form
Time frame: up to 60 mins after sound intervention
Positive and Negative Affect Score
Fatigue State Questionnaire (Change)
Time frame: baseline and up to 60 mins after sound intervention
Change in Fatigue State Questionnaire Score
1 secondary outcome
Perceived Restorativeness Soundscape Scale
Time frame: up to 60 mins after sound intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Masking Sounds and No Masking Sounds in people with Cognitive Fatigue and Mental Fatigue, run by Nanyang Technological University at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kar Fye Alvin Lee, PhD (+6591557981, alvin.lee@ntu.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reverse Corsi Task (Change) (time frame: baseline and up to 60 mins after sound intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.