Cognitive FatigueEARSNCT05009784
Effects of Natural Sounds on Attention Restoration in Noisy Environment
A study testing Baseline, Fatigue Manipulation and Traffic Sound 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 (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. 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, Heart Rate Variability
- What is being tested?
- Baseline, Fatigue Manipulation and Traffic Sound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteSingapore
- Study dates
- 25 Aug 2021to 15 Jun 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 (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.
Read the detailed 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.
- Conditions
- Cognitive Fatigue, Mental Fatigue, Heart Rate Variability, Skin Conductance, Behavioral Performance, Positive and Negative Affect
- Being tested
- Baseline, Fatigue Manipulation, Traffic Sound, Traffic and Masking Sound, Silence
- 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.
BaselineOther
5-min urban park video clip (Presented on a TV)
Fatigue ManipulationOther
20-min 2-back task (Presented on a computer)
Traffic SoundOther
Active Comparator: Traffic Sound (Played through speakers)
Traffic and Masking SoundOther
Experimental: Traffic and Masking Sound (Played through speakers)
SilenceOther
No Intervention: No sound (Played through speakers)
| Study group | Role | What they receive |
|---|---|---|
| Traffic Sound | Active comparator | 600 seconds of traffic sound Receives: Other: Baseline; Other: Fatigue Manipulation; Other: Traffic Sound |
| Traffic and Masking Sounds | Experimental | 600 seconds of traffic and masking sound Receives: Other: Baseline; Other: Fatigue Manipulation; Other: Traffic and Masking Sound |
| Silence | Active comparator | 600 seconds of no sound Receives: Other: Baseline; Other: Fatigue Manipulation; Other: Silence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reverse Corsi Task (Change)
Change in Span
Measured: up to 1 hour before and after sound intervention
Reverse Corsi Task (Change)
Change in Reaction Time
Measured: up to 1 hour before and after sound intervention
Go/NoGo Task (Change)
Change in Accuracy
Measured: up to 1 hour before and after sound intervention
Go/NoGo Task (Change)
Change in Reaction Time
Measured: up to 1 hour before and after sound Intervention
Electrocardiograph (Change)
Change in Heart Rate Variability
Measured: up to 1 hour before and after sound intervention
Electrodermal Activity (Change)
Change in Skin Conductance Level
Measured: up to 1 hour before and after sound intervention
Electrodermal Activity (Change)
Change in Skin Conductance Response
Measured: up to 1 hour before and after sound intervention
Positive and Negative Affect Schedule - Expanded Form (Change)
Change in Positive Affect Score
Measured: up to 1 hour before and after sound intervention
Positive and Negative Affect Schedule - Expanded Form (Change)
Change in Negative Affect Score
Measured: up to 1 hour before and after sound intervention
Fatigue State Questionnaire (Change)
Change in Fatigue State Questionnaire Score
Measured: up to 1 hour before and after sound intervention
Secondary outcomes (1)
Perceived Restorativeness Soundscape Scale
Perceived Restorativeness Soundscape Scale Score
Measured: up to 1 hour 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 posted18 Aug 2021
- Study start25 Aug 2021
- Primary completion15 May 2023 (estimated)
- Study completion15 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 162 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
- NCT05009784
- Sponsor's protocol ID
- COT-V4-2020-1-S001
- Acronym
- EARS
- Status last verified
- Mar 2023
- First submitted
- 10 Aug 2021
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20617017Kaplan S. The restorative benefits of nature: Toward an integrative framework. J. Environ. Psychol. 1995; 15(3): 169-182.
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 in Noisy Environment
- ClinicalTrials.gov ID
- NCT05009784
- Acronym / sponsor ID
- EARS / COT-V4-2020-1-S001
- Conditions
- Cognitive Fatigue, Mental Fatigue, Heart Rate Variability, Skin Conductance, Behavioral Performance, Positive and Negative Affect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 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
- 25 Aug 2021 (actual)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 18 Aug 2021 (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 (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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traffic Sound | Active comparator | Other: Baseline, Other: Fatigue Manipulation, Other: Traffic Sound600 seconds of traffic sound |
| Traffic and Masking Sounds | Experimental | Other: Baseline, Other: Fatigue Manipulation, Other: Traffic and Masking Sound600 seconds of traffic and masking sound |
| Silence | Active comparator | Other: Baseline, Other: Fatigue Manipulation, Other: Silence600 seconds of no sound |
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 |
|---|---|---|
| Baseline5-min urban park video clip (Presented on a TV) | Other | Silence, Traffic Sound, Traffic and Masking Sounds |
| Fatigue Manipulation20-min 2-back task (Presented on a computer) | Other | Silence, Traffic Sound, Traffic and Masking Sounds |
| Traffic SoundActive Comparator: Traffic Sound (Played through speakers) | Other | Traffic Sound |
| Traffic and Masking SoundExperimental: Traffic and Masking Sound (Played through speakers) | Other | Traffic and Masking Sounds |
| SilenceNo Intervention: No sound (Played through speakers) | Other | Silence |
Primary outcome
Reverse Corsi Task (Change)
Time frame: up to 1 hour before and after sound intervention
Change in Span
Reverse Corsi Task (Change)
Time frame: up to 1 hour before and after sound intervention
Change in Reaction Time
Go/NoGo Task (Change)
Time frame: up to 1 hour before and after sound intervention
Change in Accuracy
Go/NoGo Task (Change)
Time frame: up to 1 hour before and after sound Intervention
Change in Reaction Time
Electrocardiograph (Change)
Time frame: up to 1 hour before and after sound intervention
Change in Heart Rate Variability
Electrodermal Activity (Change)
Time frame: up to 1 hour before and after sound intervention
Change in Skin Conductance Level
Electrodermal Activity (Change)
Time frame: up to 1 hour before and after sound intervention
Change in Skin Conductance Response
Positive and Negative Affect Schedule - Expanded Form (Change)
Time frame: up to 1 hour before and after sound intervention
Change in Positive Affect Score
Positive and Negative Affect Schedule - Expanded Form (Change)
Time frame: up to 1 hour before and after sound intervention
Change in Negative Affect Score
Fatigue State Questionnaire (Change)
Time frame: up to 1 hour before and after sound intervention
Change in Fatigue State Questionnaire Score
1 secondary outcome
Perceived Restorativeness Soundscape Scale
Time frame: up to 1 hour 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.
- Background: PubMed 20617017Alvarsson 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.
- BackgroundKaplan S. The restorative benefits of nature: Toward an integrative framework. J. Environ. Psychol. 1995; 15(3): 169-182.
- 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 Baseline, Fatigue Manipulation and Traffic Sound 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: up to 1 hour before and after sound intervention). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05009784, which also lists 2 linked publications.
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.