NCT05519995

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

August 29, 2022

Status Verified

August 1, 2022

Enrollment Period

26 days

First QC Date

August 26, 2022

Last Update Submit

August 26, 2022

Conditions

Stress DisorderStress

Keywords

StressVagus NerveEmotionsSleep

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults users of Sensate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BioSelf Technology

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Traumatic

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental Disorders

Study Officials

  • Scott O McDoniel, PhD

    McDoniel Holdings, LLC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott O McDoniel, PhD

CONTACT

720-295-1409scott.mcdoniel@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2022

First Posted

August 29, 2022

Study Start

August 20, 2022

Primary Completion

September 15, 2022

Study Completion

December 1, 2022

Last Updated

August 29, 2022

Record last verified: 2022-08

Locations

GB(1)