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Sensate II Utilization and Perceived Stress in Adults

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ClinicalTrials.gov Identifier: NCT05519995
Recruitment Status : Recruiting
First Posted : August 29, 2022
Last Update Posted : August 29, 2022
Sponsor:
Information provided by (Responsible Party):
BioSelf Technology

Study Description
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Brief Summary:
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.

Condition or disease
Stress Disorder Stress

Detailed Description:

This study aims to assess the possible relationship between Sensate II utilization (Frequency, Duration, & Time) and perceived stress, affect, and sleep quality in adults.

  1. Is there a relationship between Sensate II utilization and perceived stress
  2. Is there a relationship between Sensate II utilization and postive & negative affect
  3. 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.

References 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

Garth, E. (2021). Review: Sensate stress and anxiety management. Longevity.Technology. http://longevity.technology/lifestyle/review-sensate/

Knight, S. (2021). Does the Sensate 2 do anything apart from vibrate your ribcage? http://www.makeuseof.com/sensate-review/

McDoniel, S., & Chmelik, S. (2022). A non-invasive device for stress management. https://www.researchgate.net/project/A-Non-Invasive-Wellness- Device-for-Stress-Management

Patterson, B. (2020). Sensate Meditation Device Review. http://the-gadgeteer.com/2020/07/10/sensate-meditation-device-review/

Woodhall, 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

Woolton, C. (2018). Wellness: Fear of flight. https://www.vogue.co.uk/article/fear-of-flying-sensate-review

Study Design
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Study Type : Observational
Estimated Enrollment : 360 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Relationship Between Sensate II Utilization and Perceived Stress in Adults
Actual Study Start Date : August 20, 2022
Estimated Primary Completion Date : September 15, 2022
Estimated Study Completion Date : December 1, 2022
Groups and Cohorts
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Group/Cohort
Sensate II Users
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


Outcome Measures
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Primary Outcome Measures :
  1. Perceived Stress [ Time Frame: 1-month ]
    Measure of perceived stress scale.

  2. Postive Affect [ Time Frame: 1-month ]
    Measure of positive Affect

  3. Negative Affect [ Time Frame: 1-month ]
    Measure of negative Affect

  4. Sleep Quality [ Time Frame: 1-month ]
    Measure of sleep quality


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adults users of Sensate
Criteria

Inclusion Criteria:

Inclusion 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.

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05519995


Contacts
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Contact: Scott O McDoniel, PhD 720-295-1409 scott.mcdoniel@gmail.com

Locations
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United Kingdom
BioSelf Technology Recruiting
London, United Kingdom
Contact: Stefan Chmelik, MSc         
Sponsors and Collaborators
BioSelf Technology
Investigators
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Principal Investigator: Scott O McDoniel, PhD McDoniel Holdings, LLC
More Information
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Responsible Party: BioSelf Technology
ClinicalTrials.gov Identifier: NCT05519995    
Other Study ID Numbers: #2022/07/14
First Posted: August 29, 2022    Key Record Dates
Last Update Posted: August 29, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Perceived Stress Scale, Positive / Negative Affect, & Discrete Emotions, Utilization of Sensate

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by BioSelf Technology:
Stress
Vagus Nerve
Emotions
Sleep
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders