Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT07206251
Status:
COMPLETED
Last Update Posted:
2025-10-03
First Post:
2025-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of the Window Films on Cognition, Perception, and Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2025-03-20', 'studyFirstSubmitQcDate': '2025-09-25', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive Performance Scores', 'timeFrame': '5 hours', 'description': 'Participants completed 2 cognitive battery tests (Creyos) during each test day at 2 different timepoints; one early afternoon, the other late afternon.'}], 'secondaryOutcomes': [{'measure': 'Skin Temperature', 'timeFrame': '5 hours', 'description': 'Temperature in celsius'}, {'measure': 'Visual Scale', 'timeFrame': '5 hours', 'description': 'Visual perceptual likert scales'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Window Foil', 'Thermoregulation', 'Thermal Perception', 'Daylight', 'Saliva', 'Cognition'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To enable the Netherlands to reach the 2030 carbon emission goals, older homes need to be renovated to become more energy-efficient and comfortable. This project aims to provide shallow renovations of window films. These shallow renovations can be completed in 1-2 days and cost significantly less than a deep renovation. We would like to investigate how such window films can affect humans (low-e film and thermochromatic) if applicated in real life.', 'detailedDescription': 'This study consists of one screening session (1.5 hours) and two testing sessions (5.5 hours each)\n\nScreening session:\n\nIn the screening session, participants will fill in a questionnaire about their general information as well as a medical questionnaire that asks about, current health status, lifestyle, morningness-eveningness chronotype, use of contraceptives, and sleep quality. This data is necessary to assess the eligibility to participate and to analyse the collected data with consideration of possible effect of lifestyle of the participant.\n\nTesting sessions:\n\nSubjects will be exposed to 2 different conditions (window film vs. no window film) in two days (11:15- 16:45) to assess the window film(s) influence on visual and temperature comfort, sensation and perception. The exposure rooms are low-e film room (film 1) or a thermochromic film room (film 2), compared with no film room (control). These films will be applied to windows. Participants will perform 2 cognitive tests, 2 vision tasks and fill in questionanires at set times. They will also wear the sensors mentiond in Part 3 section 2 (wearable sensors) to measure their physiological parametersm suchs as skin temperature, heart rate and physical activity. Lastly, every hour they will provide a saliva sample by spitting into a tube to measure the cortisol level in the saliva. Saliva is collected to measure cortisol changes caused by the environment. The participants only saliva is collected by a cotton swap from a saliva collection tube (salivattes). The samples are then stored immediately in a -20 freezer, after it is transported to the storage lab they will be centrifuged for 2 mins at 1000g and then stored in a\n\n-80 freezer for the duration of the study until analysis. The storage room is secured and only the research team can assess the samples. When they are to be analyzed for cortisol, the sample is defrosted and tested by a spectrophotometer to quantify the amount of cortisol. The sample is then discarded after this analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Generally Healthy Adult\n* Ages between 19-40 years old\n* Normal or correct vision (with use of glasses or contact lenses)\n* Full vision\n* Both males or females\n\nExclusion Criteria:\n\n* No Raynaud's syndrome\n* No metabolic or cardiovascular diseases\n* No ADHD or cognitive disorders\n* No night shift work\n* No colour blindness"}, 'identificationModule': {'nctId': 'NCT07206251', 'acronym': 'FOIL', 'briefTitle': 'The Effect of the Window Films on Cognition, Perception, and Health', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'The Effect of the Window Films on Cognition, Perception, and Health', 'orgStudyIdInfo': {'id': 'ERB2024BE34'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Regular Windowed room (no foil added)', 'description': 'Regular Windowed room (no foil added)'}, {'type': 'EXPERIMENTAL', 'label': 'Foiled Windowed room (foil added)', 'description': 'Foiled Windowed room (foil added)', 'interventionNames': ['Behavioral: Foiled Windowed room (foil added)']}], 'interventions': [{'name': 'Foiled Windowed room (foil added)', 'type': 'BEHAVIORAL', 'description': 'Foiled Windowed room (foil added)', 'armGroupLabels': ['Foiled Windowed room (foil added)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5612 AV', 'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Vertigo - TU/e', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Study is conducted by the researchers who will also process and analyse the data set anonymoously.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eindhoven University of Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}