Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-01-02 @ 1:16 AM
Study NCT ID:
NCT05679869
Status:
UNKNOWN
Last Update Posted:
2023-01-11
First Post:
2022-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Natural Sounds on Attention Restoration in Virtual Reality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005222', 'term': 'Mental Fatigue'}], 'ancestors': [{'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-10', 'studyFirstSubmitDate': '2022-09-05', 'studyFirstSubmitQcDate': '2023-01-10', 'lastUpdatePostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Heart Rate Variability', 'timeFrame': '1 day (during fatiguing task and sound intervention)', 'description': 'Electrocardiograph (Change)'}, {'measure': 'Change in Fatigue State Questionnaire', 'timeFrame': 'baseline, up to 2 mins after fatiguing task and up to 2 mins after sound intervention', 'description': 'Change in Fatigue State Questionnaire Score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Fatigue', 'Mental Fatigue', 'Behavioral Performance', 'Heart Rate Variability', 'Working Memory']}, 'descriptionModule': {'briefSummary': 'This study aims to examine whether listening to natural sounds in a noisy virtual reality environment compared to no natural sounds influences physiological markers.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singapore-based\n* Non-clinical\n* 18-35years\n\nExclusion Criteria:\n\n* Individuals with hearing difficulties or failing to meet the minimal threshold for normal hearing\n* Individuals with a history of ear, developmental, neurological, or psychiatric disorder'}, 'identificationModule': {'nctId': 'NCT05679869', 'acronym': 'VEARS', 'briefTitle': 'Effects of Natural Sounds on Attention Restoration in Virtual Reality', 'organization': {'class': 'OTHER', 'fullName': 'Nanyang Technological University'}, 'officialTitle': 'Effects of Natural Sounds on Attention Restoration in Virtual Reality', 'orgStudyIdInfo': {'id': 'COT-V4-2020-1-S005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'VR Simulated Outdoor Environment', 'description': 'Exposure to recorded outdoor environmental sounds', 'interventionNames': ['Other: No masking sound']}, {'type': 'EXPERIMENTAL', 'label': 'VR Simulated Outdoor Environment with Masking Sounds', 'description': 'Exposure to recorded outdoor environmental sounds augmented with masking sounds', 'interventionNames': ['Other: Masking Sound']}], 'interventions': [{'name': 'Masking Sound', 'type': 'OTHER', 'description': 'Prerecorded environmental noise and masking sounds played from headphones', 'armGroupLabels': ['VR Simulated Outdoor Environment with Masking Sounds']}, {'name': 'No masking sound', 'type': 'OTHER', 'description': 'Prerecorded environmental noise but no masking sounds played from headphones', 'armGroupLabels': ['VR Simulated Outdoor Environment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '639798', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Elliot Chan, B.A.', 'role': 'CONTACT', 'email': 'elliotchan@ntu.edu.sg', 'phone': '+6596799914'}], 'facility': 'Cultural Science Innovations, Nanyang Technological University', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Kar Fye Alvin Lee, PhD', 'role': 'CONTACT', 'email': 'alvin.lee@ntu.edu.sg', 'phone': '+6591557981'}, {'name': 'GEORGIOS CHRISTOPOULOS, PhD', 'role': 'CONTACT', 'email': 'georchris7@gmail.com', 'phone': '+6594898379'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanyang Technological University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Foundation, Singapore', 'class': 'OTHER_GOV'}, {'name': 'Ministry of National Development, Singapore', 'class': 'OTHER_GOV'}, {'name': 'Housing and Development Board, Singapore', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Georgios CHRISTOPOULOS', 'investigatorAffiliation': 'Nanyang Technological University'}}}}