An observational study in Stress Disorder and Stress, sponsored by BioSelf Technology. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-29.
Sponsored by BioSelf Technology · Observational
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.
This study aims to assess the possible relationship between Sensate II utilization (Frequency, Duration, \& Time) and perceived stress, affect, and sleep quality in adults.
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
1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
This study's planned enrollment of 360 is above the median of 140 across 177 observational studies indexed under Stress Disorders, Traumatic.
Browse Stress Disorders, Traumatic studies →This is the only study on the registry with BioSelf Technology as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Adults users of Sensate
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:
-
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
Perceived Stress
Measure of perceived stress scale.
Time frame: 1-month
Postive Affect
Measure of positive Affect
Time frame: 1-month
Negative Affect
Measure of negative Affect
Time frame: 1-month
Sleep Quality
Measure of sleep quality
Time frame: 1-month
Plan to share: Undecided — Perceived Stress Scale, Positive / Negative Affect, \& Discrete Emotions, Utilization of Sensate
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.