Acute Stress Recovery (ASR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stress
• Intervention / Treatment: Behavioral: MindBreaks - Audio-visual; Behavioral: MindBreaks - Auditory-only; Behavioral: MindBreaks - Visual-only

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kevin A Mazurek, PhD; Phone Number: 507-258-7592; Email: kevin.mazurek@delos.com

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Recruiting
      • Well Living Lab Inc.
      • Contact: Eric Heins; Phone Number: 507-259-0611; Email: eric.heins@delos.com
      • Principal Investigator: Colin P West, MD, Ph.D
      • Sub-Investigator: Kevin A Mazurek, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
Experimental: Audio-visual Group	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.
Experimental: Auditory-only Group; This group will recover in the relaxation room with only auditory stimuli.	Behavioral: 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.
Experimental: Visual-only group	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Well Living Lab, Inc.
• Collaborators: Mayo Clinic; Delos Living LLC

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IRB 21-005885

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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