Sensate II Utilization and Perceived Stress in Adults

Stress Clinical Trial

Official title:

The Relationship Between Sensate II Utilization and Perceived Stress in Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05519995
• Other study ID #: #2022/07/14
• Status: Recruiting
• 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
• 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: -

Related Conditions & MeSH terms

• Stress
• Stress Disorder
• Stress Disorders, Traumatic

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