Effects of Natural Sounds on Attention Restoration in Noisy Environment (EARS)

March 21, 2023 updated by: Georgios CHRISTOPOULOS, Nanyang Technological University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
162

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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, 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Traffic Sound
600 seconds of traffic sound
Other: Baseline
5-min urban park video clip (Presented on a TV)
Other: Fatigue Manipulation
20-min 2-back task (Presented on a computer)
Other: Traffic Sound
Active Comparator: Traffic Sound (Played through speakers)
Experimental: Traffic and Masking Sounds
600 seconds of traffic and masking sound
Other: Baseline
5-min urban park video clip (Presented on a TV)
Other: Fatigue Manipulation
20-min 2-back task (Presented on a computer)
Other: Traffic and Masking Sound
Experimental: Traffic and Masking Sound (Played through speakers)
Active Comparator: Silence
600 seconds of no sound
Other: Baseline
5-min urban park video clip (Presented on a TV)
Other: Fatigue Manipulation
20-min 2-back task (Presented on a computer)
Other: Silence
No Intervention: No sound (Played through speakers)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reverse Corsi Task (Change)
Time Frame: up to 1 hour before and after sound intervention
Change in Span
up to 1 hour before and after sound intervention
Reverse Corsi Task (Change)
Time Frame: up to 1 hour before and after sound intervention
Change in Reaction Time
up to 1 hour before and after sound intervention
Go/NoGo Task (Change)
Time Frame: up to 1 hour before and after sound intervention
Change in Accuracy
up to 1 hour before and after sound intervention
Go/NoGo Task (Change)
Time Frame: up to 1 hour before and after sound Intervention
Change in Reaction Time
up to 1 hour before and after sound Intervention
Electrocardiograph (Change)
Time Frame: up to 1 hour before and after sound intervention
Change in Heart Rate Variability
up to 1 hour before and after sound intervention
Electrodermal Activity (Change)
Time Frame: up to 1 hour before and after sound intervention
Change in Skin Conductance Level
up to 1 hour before and after sound intervention
Electrodermal Activity (Change)
Time Frame: up to 1 hour before and after sound intervention
Change in Skin Conductance Response
up to 1 hour before and after sound intervention
Positive and Negative Affect Schedule - Expanded Form (Change)
Time Frame: up to 1 hour before and after sound intervention
Change in Positive Affect Score
up to 1 hour before and after sound intervention
Positive and Negative Affect Schedule - Expanded Form (Change)
Time Frame: up to 1 hour before and after sound intervention
Change in Negative Affect Score
up to 1 hour before and after sound intervention
Fatigue State Questionnaire (Change)
Time Frame: up to 1 hour before and after sound intervention
Change in Fatigue State Questionnaire Score
up to 1 hour before and after sound intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceived Restorativeness Soundscape Scale
Time Frame: up to 1 hour after sound Intervention
Perceived Restorativeness Soundscape Scale Score
up to 1 hour after sound Intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanyang Technological University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Research Foundation, Singapore
Ministry of National Development, Singapore
Housing and Development Board, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 25, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COT-V4-2020-1-S001

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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