Cognitive FatigueVEARSNCT05679869
Effects of Natural Sounds on Attention Restoration in Virtual Reality
A study testing Masking Sound and No masking 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 virtual reality environment compared to no natural sounds influences 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 Sound and No masking sound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- 6 Dec 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 virtual reality environment compared to no natural sounds influences 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 environment will have greater restorative effects on attention (i.e., physiological) 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.
- Conditions
- Cognitive Fatigue, Mental Fatigue, Behavioral Performance, Heart Rate Variability, Working Memory
- Being tested
- Masking Sound, No masking sound
- Medical subject headings
- Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masking SoundOther
Prerecorded environmental noise and masking sounds played from headphones
No masking soundOther
Prerecorded environmental noise but no masking sounds played from headphones
| Study group | Role | What they receive |
|---|---|---|
| VR Simulated Outdoor Environment | Active comparator | Exposure to recorded outdoor environmental sounds Receives: Other: No masking sound |
| VR Simulated Outdoor Environment with Masking Sounds | Experimental | Exposure to recorded outdoor environmental sounds augmented with masking sounds Receives: Other: Masking Sound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart Rate Variability
Electrocardiograph (Change)
Measured: 1 day (during fatiguing task and sound intervention)
Change in Fatigue State Questionnaire
Change in Fatigue State Questionnaire Score
Measured: baseline, up to 2 mins after fatiguing task and up to 2 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 start6 Dec 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
- NCT05679869
- Sponsor's protocol ID
- COT-V4-2020-1-S005
- Acronym
- VEARS
- Status last verified
- Jan 2023
- First submitted
- 5 Sep 2022
- Last updated
- 11 Jan 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 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Natural Sounds on Attention Restoration in Virtual Reality
- ClinicalTrials.gov ID
- NCT05679869
- Acronym / sponsor ID
- VEARS / COT-V4-2020-1-S005
- Conditions
- Cognitive Fatigue, Mental Fatigue, Behavioral Performance, Heart Rate Variability, Working Memory
- 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
- 6 Dec 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 virtual reality environment compared to no natural sounds influences 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 environment will have greater restorative effects on attention (i.e., physiological) 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR Simulated Outdoor Environment | Active comparator | Other: No masking soundExposure to recorded outdoor environmental sounds |
| VR Simulated Outdoor Environment with Masking Sounds | Experimental | Other: Masking SoundExposure to recorded outdoor environmental sounds augmented with 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 SoundPrerecorded environmental noise and masking sounds played from headphones | Other | VR Simulated Outdoor Environment with Masking Sounds |
| No masking soundPrerecorded environmental noise but no masking sounds played from headphones | Other | VR Simulated Outdoor Environment |
Primary outcome
Change in Heart Rate Variability
Time frame: 1 day (during fatiguing task and sound intervention)
Electrocardiograph (Change)
Change in Fatigue State Questionnaire
Time frame: baseline, up to 2 mins after fatiguing task and up to 2 mins after sound intervention
Change in Fatigue State Questionnaire Score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 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 Sound and No masking 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 11 Jan 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?
Change in Heart Rate Variability (time frame: 1 day (during fatiguing task and sound intervention)). The study lists 2 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 11 Jan 2023.