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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05519995
Other study ID # #2022/07/14
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 20, 2022
Est. completion date December 1, 2022

Study information

Verified date August 2022
Source BioSelf Technology
Contact Scott O McDoniel, PhD
Phone 720-295-1409
Email scott.mcdoniel@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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-nerv e-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


Recruitment information / eligibility

Status Recruiting
Enrollment 360
Est. completion date December 1, 2022
Est. primary completion date September 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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: -

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom BioSelf Technology London

Sponsors (1)

Lead Sponsor Collaborator
BioSelf Technology

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perceived Stress Measure of perceived stress scale. 1-month
Primary Postive Affect Measure of positive Affect 1-month
Primary Negative Affect Measure of negative Affect 1-month
Primary Sleep Quality Measure of sleep quality 1-month
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