Sensate II Utilization and Perceived Stress in Adults

The Relationship Between Sensate II Utilization and Perceived Stress in Adults

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.

Study Overview

• Status: Recruiting
• Conditions: Stress; Stress Disorder

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 Type: Observational
• Enrollment (Anticipated): 360

Contacts and Locations

• Study Contact: Name: Scott O McDoniel, PhD; Phone Number: 720-295-1409; Email: scott.mcdoniel@gmail.com

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • BioSelf Technology
    • Contact: Stefan Chmelik, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adults users of Sensate

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress	Measure of perceived stress scale.	1-month
Postive Affect	Measure of positive Affect	1-month
Negative Affect	Measure of negative Affect	1-month
Sleep Quality	Measure of sleep quality	1-month

Collaborators and Investigators

• Sponsor: BioSelf Technology
• Investigators: Principal Investigator: Scott O McDoniel, PhD, McDoniel Holdings, LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2022
• Primary Completion (Anticipated): September 15, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: August 26, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 26, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Stress; Sleep; Emotions; Vagus Nerve
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic
• Other Study ID Numbers: #2022/07/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Perceived Stress Scale, Positive / Negative Affect, & Discrete Emotions, Utilization of Sensate

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No