Clinical trial NCT05298189: Acute Stress Recovery
Official title: Understanding How Cognitive Performance and Physiological Measures Change After Acute Stress and How Different Sensory Features of a Relaxation Room Help Recover
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress
Lead sponsor: Well Living Lab, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Mayo Clinic
name: Delos Living LLC
First posted: 2022-03-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.).

Primary outcomes:
measure: Change in cognitive performance relative to baseline
timeFrame: 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
measure: Change in perceived stress relative to baseline
timeFrame: 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
measure: Change in heart rate relative to baseline
timeFrame: 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
measure: Change in electroencephalography (EEG) alpha band power relative to baseline
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Well Living Lab Inc.
state: Minnesota
Study officials:
References: