Acute Stress Recovery

Stress Clinical Trial

— ASR  

Official title:

Understanding How Cognitive Performance and Physiological Measures Change After Acute Stress and How Different Sensory Features of a Relaxation Room Help Recover

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05298189
• Other study ID #: IRB 21-005885
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2022
• Source: Well Living Lab, Inc.
• Contact: Kevin A Mazurek, PhD
• Phone: 507-258-7592
• Email: kevin.mazurek[@]delos.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed study aims to evaluate whether different features of a relaxation room affect how individuals recover from acute stress. This study will use a unique methodology to capture participants' physiological and behavioral measures through a combination of non-invasive technologies, including wearables devices, active sensors, cognitive tasks, and/or subjective questionnaires. Participants will perform a stress induction task, after which they will rest in a relaxation room. Physiological measures and cognitive performance will be recorded throughout the experiment to determine whether features of the relaxation room promote recovery after acute stress. Identifying the occurrence of stress and ways to potentially reduce the effects of stress could lead to novel interventions for helping individuals reduce work-related stress.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adults at least age 18

2. Participants are able to remain in the Well Living Lab for 3-4 hours

3. Participants are able to perform scripted tasks

4. Participants are able to provide informed consent

5. Participants are able to wear the wearable devices at all times during the study

6. Participants have completed a COVID vaccine regimen and can provide written documentation verifying vaccination status at least fourteen (14) days prior to the commencement of the research study

Exclusion Criteria:

1. Participants with a reported history of diagnosed mood, anxiety, or major health disorders

2. Participants who have used steroid-based medications within the past three years

3. Participants with a history of drug/alcohol abuse

4. Participants with or recovering from nicotine dependency who cannot use a nicotine patch

5. Participants who consume excessive amounts of caffeine

6. Participants who have had severe sleep disturbance (e.g., shift work, chronic insomnia)

7. Women who are pregnant or intend to become pregnant at the time of the study

8. Participants with a history of diagnosed cognitive impairment

9. Participants taking any medications that might affect the physiological measures of interest

10. Participants with anything that might affect collecting the physiological measures of interest (e.g., cosmetic products, head coverings, head products, etc.).

Related Conditions & MeSH terms

• Stress

Intervention

Behavioral:
• MindBreaks - Audio-visual
A "MindBreaks" room is designed to deliver short, effective, and restorative breaks to help increase energy, reduce stress, enhance mood, improve focus, and boost performance. For this intervention, the MindBreaks room will contain visual and auditory stimuli.
• MindBreaks - Auditory-only
A "MindBreaks" room is designed to deliver short, effective, and restorative breaks to help increase energy, reduce stress, enhance mood, improve focus, and boost performance. For this intervention, the MindBreaks room will contain only auditory stimuli.
• MindBreaks - Visual-only
A "MindBreaks" room is designed to deliver short, effective, and restorative breaks to help increase energy, reduce stress, enhance mood, improve focus, and boost performance. For this intervention, the MindBreaks room will contain only visual stimuli.

Locations

Country	Name	City	State
United States	Well Living Lab Inc.	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Well Living Lab, Inc.	Delos Living LLC, Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognitive performance relative to baseline	Participants will perform the operational SPAN (OSPAN) and symmetry SPAN (SSPAN) working memory assessments at 5 time points throughout the experimental session. The unit score and load score from these assessments are used to measure changes in working memory cognitive performance. Measurements are taken at approximately -35 minutes, -5 minutes, +15 minutes, +35 minutes, and +55 minutes relative to the start of the stress induction task (Trier social stress test, TSST). Each measure will be compared with the -35 minute baseline measurement to detect a change in performance.; [Note: times are approximate as there might be slight temporal changes due to the self-paced duration it takes each participant to complete certain portions of the experiment].	throughout the one day experimental session at time points approximately -35 minutes, -5 minutes, +15 minutes, +35 minutes, +55 minutes relative to the start of the stress induction task
Primary	Change in perceived stress relative to baseline	Measures of perceived stress from self-reported surveys will be compared before, during and after a stress induction task relative to baseline. Surveys are completed after the cognitive assessments and during the stress induction task. Measurements are taken at approximately -35 minutes, -5 minutes, +5 minutes, +10 minutes, +15 minutes, +35 minutes, and +55 minutes relative to the start of the stress induction task (Trier social stress test, TSST). Each measure will be compared with the -35 minute baseline measurement to detect a change in performance.; [Note: times are approximate as there might be slight temporal changes due to the self-paced duration it takes each participant to complete certain portions of the experiment].	throughout the one day experimental session at time points approximately -35 minutes, -5 minutes, +5 minutes, +15 minutes, +35 minutes, +55 minutes relative to the start of the stress induction task
Primary	Change in heart rate relative to baseline	Measures of heart rate from wearable devices will be compared before, during and after a stress induction task. Heart rate will be measured continuously and binned during the following epochs of the experimental session (all times relative to the start of the stress induction task and are approximates due to some temporal delays in transitioning between epochs): baseline (-35 minutes to -5 minutes), stress induction task (+0 to +15 minutes), recovery period #1 (+15 to +35 minutes), recovery period #2 (+35 to +55 minutes).; [Note: times are approximate as there might be slight temporal changes due to the self-paced duration it takes each participant to complete certain portions of the experiment].	throughout the one day experimental session during baseline (-35 minutes to -5 minutes), stress induction task (+0 to +15 minutes), recovery period #1 (+15 to +35 minutes), recovery period #2 (+35 to +55 minutes) epochs
Primary	Change in electroencephalography (EEG) alpha band power relative to baseline	Measures of neural activity, (electroencephalography, EEG) from a wearable device will be compared before, during and after a stress induction task. Alpha band power will be measured and binned during the following epochs of the experimental session (all times relative to the start of the stress induction task and are approximates due to some temporal delays in transitioning between epochs): baseline (-35 minutes to -5 minutes), stress induction task (+0 to +15 minutes), recovery period #1 (+15 to +35 minutes), recovery period #2 (+35 to +55 minutes).; [Note: times are approximate as there might be slight temporal changes due to the self-paced duration it takes each participant to complete certain portions of the experiment].	throughout the one day experimental session during baseline (-35 minutes to -5 minutes), stress induction task (+0 to +15 minutes), recovery period #1 (+15 to +35 minutes), recovery period #2 (+35 to +55 minutes) epochs