StressASRNCT05298189
Acute Stress Recovery
A study testing MindBreaks - Audio-visual, MindBreaks - Auditory-only and MindBreaks - Visual-only in people with Stress, run by Well Living Lab, Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- MindBreaks - Audio-visual, MindBreaks - Auditory-only and MindBreaks - Visual-only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2021to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults at least age 18
- Participants are able to remain in the Well Living Lab for 3-4 hours
- Participants are able to perform scripted tasks
- Participants are able to provide informed consent
- Participants are able to wear the wearable devices at all times during the study
- 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
Who cannot join
- Participants with a reported history of diagnosed mood, anxiety, or major health disorders
- Participants who have used steroid-based medications within the past three years
- Participants with a history of drug/alcohol abuse
- Participants with or recovering from nicotine dependency who cannot use a nicotine patch
- Participants who consume excessive amounts of caffeine
- Participants who have had severe sleep disturbance (e.g., shift work, chronic insomnia)
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- Women who are pregnant or intend to become pregnant at the time of the study
- Participants with a history of diagnosed cognitive impairment
- Participants taking any medications that might affect the physiological measures of interest
- Participants with anything that might affect collecting the physiological measures of interest (e.g., cosmetic products, head coverings, head products, etc.).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Well Living Lab Inc.
Rochester, Minnesota, 55902
Eric Heins, 507-259-0611, eric.heins@delos.com
Colin P West, MD, Ph.D
About this study
Official title: 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.
- Conditions
- Stress
- Being tested
- MindBreaks - Audio-visual, MindBreaks - Auditory-only, MindBreaks - Visual-only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindBreaks - Audio-visualBehavioural
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-onlyBehavioural
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-onlyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Audio-visual Group | Experimental | Not described Receives: Behavioral: MindBreaks - Audio-visual |
| Auditory-only Group | Experimental | This group will recover in the relaxation room with only auditory stimuli. Receives: Behavioral: MindBreaks - Auditory-only |
| Visual-only group | Experimental | Not described Receives: Behavioral: MindBreaks - Visual-only |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: 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].
Measured: 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].
Measured: 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].
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start2 Dec 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Well Living Lab, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic, Delos Living LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298189
- Sponsor's protocol ID
- IRB 21-005885
- Acronym
- ASR
- Status last verified
- Mar 2022
- First submitted
- 3 Mar 2022
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding How Cognitive Performance and Physiological Measures Change After Acute Stress and How Different Sensory Features of a Relaxation Room Help Recover
- ClinicalTrials.gov ID
- NCT05298189
- Acronym / sponsor ID
- ASR / IRB 21-005885
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Well Living Lab, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic, Delos Living LLC
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Audio-visual Group | Experimental | Behavioral: MindBreaks - Audio-visual |
| Auditory-only Group | Experimental | Behavioral: MindBreaks - Auditory-onlyThis group will recover in the relaxation room with only auditory stimuli. |
| Visual-only group | Experimental | Behavioral: MindBreaks - Visual-only |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults at least age 18
- Participants are able to remain in the Well Living Lab for 3-4 hours
- Participants are able to perform scripted tasks
- Participants are able to provide informed consent
- Participants are able to wear the wearable devices at all times during the study
Key exclusion criteria (10 listed)
- Participants with a reported history of diagnosed mood, anxiety, or major health disorders
- Participants who have used steroid-based medications within the past three years
- Participants with a history of drug/alcohol abuse
- Participants with or recovering from nicotine dependency who cannot use a nicotine patch
- Participants who consume excessive amounts of caffeine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindBreaks - Audio-visualA "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. | Behavioural | Audio-visual Group |
| MindBreaks - Auditory-onlyA "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. | Behavioural | Auditory-only Group |
| MindBreaks - Visual-onlyA "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. | Behavioural | Visual-only group |
Primary outcome
Change in cognitive performance relative to baseline
Time frame: 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
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].
Change in perceived stress relative to baseline
Time frame: 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
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].
Change in heart rate relative to baseline
Time frame: 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
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].
Change in electroencephalography (EEG) alpha band power relative to baseline
Time frame: 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
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].
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MindBreaks - Audio-visual, MindBreaks - Auditory-only and MindBreaks - Visual-only in people with Stress, run by Well Living Lab, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kevin A Mazurek, PhD (507-258-7592, kevin.mazurek@delos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive performance relative to baseline (time frame: 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.