Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-01-01 @ 1:05 PM
Study NCT ID:
NCT05519995
Status:
UNKNOWN
Last Update Posted:
2022-08-29
First Post:
2022-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensate II Utilization and Perceived Stress in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}], 'ancestors': [{'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-26', 'studyFirstSubmitDate': '2022-08-26', 'studyFirstSubmitQcDate': '2022-08-26', 'lastUpdatePostDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived Stress', 'timeFrame': '1-month', 'description': 'Measure of perceived stress scale.'}, {'measure': 'Postive Affect', 'timeFrame': '1-month', 'description': 'Measure of positive Affect'}, {'measure': 'Negative Affect', 'timeFrame': '1-month', 'description': 'Measure of negative Affect'}, {'measure': 'Sleep Quality', 'timeFrame': '1-month', 'description': 'Measure of sleep quality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'keywords': ['Stress', 'Vagus Nerve', 'Emotions', 'Sleep'], 'conditions': ['Stress Disorder', 'Stress']}, 'descriptionModule': {'briefSummary': 'Sensate® is A commercially marketed (FCC #: 2AS9ESEN231) stress management wellness device (BioSelf Technology; London, UK). This non-invasive wellness device is one component of a cross-modal (acoustic and aural) sensory experience designed to help an individual experience relaxation following a 10 to 30-minute session. The wellness device is paired with an in-app software program that offers infrasonic vibrations that are proprietarily synced to music or soundscapes. The wellness device is recommended in blogs, and online news articles as a possible modality for positive stress management (Bergland, 2017; Woodhall, 2018; Woolton, 2018), and anecdotal evidence from social media influencers suggest a relaxing response (Garth, 2021; Knight, 2021; Patterson, 2020). Moreover, a 2021 survey response from consumers of Sensate suggests an improvement in stress response during the COVID-19 pandemic (McDoniel \\& Chmelik, 2022). However, it is unknown to what extent, if any, the use of Sensate II correlated with validated measures of stress, affect, or sleep quality in adults.', 'detailedDescription': 'This study aims to assess the possible relationship between Sensate II utilization (Frequency, Duration, \\& Time) and perceived stress, affect, and sleep quality in adults.\n\n1. Is there a relationship between Sensate II utilization and perceived stress\n2. Is there a relationship between Sensate II utilization and postive \\& negative affect\n3. Is there a relationship between Sensate II utilization and sleep quality. It is hypothesized that significant relationship existis between Sensate II utilization and perceived lower stress, higher postive affect, lower negative affect, and sleep quality.\n\nReferences Bergland, C. (2017). Will stress-busting vagus nerve gadgetry be a game changer? Non-invasive vagus nerve stimulation reduces "fight-or-flight" stress responses. Psychology Today. http://www.psychologytoday.com/us/blog/the-athletes-way/201711/will-stress-busting-vagus-nerve-gadgetry-be-gamechanger\n\nGarth, E. (2021). Review: Sensate stress and anxiety management. Longevity.Technology. http://longevity.technology/lifestyle/review-sensate/\n\nKnight, S. (2021). Does the Sensate 2 do anything apart from vibrate your ribcage? http://www.makeuseof.com/sensate-review/\n\nMcDoniel, S., \\& Chmelik, S. (2022). A non-invasive device for stress management. https://www.researchgate.net/project/A-Non-Invasive-Wellness- Device-for-Stress-Management\n\nPatterson, B. (2020). Sensate Meditation Device Review. http://the-gadgeteer.com/2020/07/10/sensate-meditation-device-review/\n\nWoodhall, V. (2018). Vagus nerve: The new key to stress relief and good health. The Times. https://www.thetimes.co.uk/article/vagus-nerve-the-new-keyto- stress-relief-and-good-health-b0778h20q\n\nWoolton, C. (2018). Wellness: Fear of flight. https://www.vogue.co.uk/article/fear-of-flying-sensate-review'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults users of Sensate', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion for this study will be adults (18+ years of age) who have been using the Sensate II device for stress management for a minimum of 30-days or one month.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05519995', 'briefTitle': 'Sensate II Utilization and Perceived Stress in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioSelf Technology'}, 'officialTitle': 'The Relationship Between Sensate II Utilization and Perceived Stress in Adults', 'orgStudyIdInfo': {'id': '#2022/07/14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sensate II Users', 'description': 'Users will be adults (18+ years of age) who have been using the Sensate II device for stress management for a minimum of 30-days or 1-month'}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Stefan Chmelik, MSc', 'role': 'CONTACT'}], 'facility': 'BioSelf Technology', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Scott O McDoniel, PhD', 'role': 'CONTACT', 'email': 'scott.mcdoniel@gmail.com', 'phone': '720-295-1409'}], 'overallOfficials': [{'name': 'Scott O McDoniel, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McDoniel Holdings, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Perceived Stress Scale, Positive / Negative Affect, \\& Discrete Emotions, Utilization of Sensate'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioSelf Technology', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}