SleepACESNCT07431970
Assessing Construction Execution Under Sleep Impairment
A study testing Construction Virtual Reality Stress Challenges and No Construction Virtual Reality Stress Challenges in people with Sleep, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The goal of this study is to learn whether virtual reality (VR) construction tasks can detect performance changes associated with prior sleep, and to determine the extent to which these changes can be distinguished from interacting repetitively with VR itself. Read more about this study
- Who is it for?
- Ages 21 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Construction Virtual Reality Stress Challenges and No Construction Virtual Reality Stress Challenges
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fluent in English
- Tolerate virtual reality system
Who cannot join
- Recent shiftwork
- Recent travel across time zones (>2 in last month)
- Underlying health conditions (high blood pressure, diabetes, cancer, heart attack, heart failure, angioplasty, heart surgery, etc.)
- Use of nicotine products such as tobacco or e-cigarettes
- Use of illicit drugs in the past year
- Pregnancy
- Sleep disorders (obstructive sleep apnea)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
Nicole P Bowles, PhD, 503-494-2541, bowlesn@ohsu.edu
Nicole P Bowles, PhD
About this study
Official title: Feasibility of VR Construction Simulations for Detecting Sleep-Related Impairments
The goal of this study is to learn whether virtual reality (VR) construction tasks can detect performance changes associated with prior sleep, and to determine the extent to which these changes can be distinguished from interacting repetitively with VR itself.
Read the detailed description
After passing a physical assessment and psychological screen, up to 12 participants will be enrolled. Ahead of each 8-hour in-laboratory assessment, participants will be asked to participate in a 1-week at-home monitoring period while continuing with their regular sleep/wake schedule. During this at-home assessment participants will be asked to wear an ActiGraph to objectively assess sleep and complete daily sleep diaries and call into a time-stamped voice-mailbox when going to bed and getting out of bed to confirm sleep/wake times. Participants will be asked to refrain from any alcohol, substances, or intense physical activity during each 1-week at home monitoring period. Similarly, participants are asked to refrain from caffeine consumption 5h prior to the in lab. Participants will then participate in two 8-hour sessions in an in-laboratory setting with a 1-week washout period in-between each in-laboratory visit. The two 8-hour visits will be identical in schedule and instrumentation, differing only in whether VR tasks are administered. Order of visits will be randomized. At each visit, participants will arrive to the laboratory ~6h after their habitual waketime (determined from daily call-ins) and be hooked up for ECG and beat-by-beat blood pressure. They will wear an ActiGraph the entire in-laboratory visit. Participants will also be asked to complete the Karolinska Sleepiness Scale (KSS) questionnaire and the modified Positive Affect-Negative Affect Schedule (PANAS) and the Profile of Mood States (POMS) questionnaire. Finally, participants will be asked to complete construction virtual reality tasks using a virtual reality headset during each of the 4 time points at each visit.
- Conditions
- Sleep
- Being tested
- Construction Virtual Reality Stress Challenges, No Construction Virtual Reality Stress Challenges
- Keywords
- Occupational Health, Construction, Sleep, Virtual Reality, Sleep Impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Construction Virtual Reality Stress ChallengesOther
Participants will be randomly assigned to a laboratory visit that will contain construction virtual reality stress challenges.
No Construction Virtual Reality Stress ChallengesOther
Participants will be randomly assigned to a laboratory visit that will not contain construction virtual reality stress challenges.
| Study group | Role | What they receive |
|---|---|---|
| Construction Virtual Reality Stress Challenges | Experimental | Participants will be randomly assigned to a laboratory visit that will contain construction virtual reality stress challenges. Receives: Other: Construction Virtual Reality Stress Challenges |
| No Construction Virtual Reality Stress Challenges | Experimental | Participants will be randomly assigned to a laboratory visit that will not contain construction virtual reality stress challenges. Receives: Other: No Construction Virtual Reality Stress Challenges |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Recruitment
Number of eligible participants who enroll in the study.
Measured: From first date of recruitment activities to last day of study activities, up to 100 weeks.
Feasibility: Retention
Proportion of eligible participants who enroll and complete all scheduled study visits.
Measured: From start of recruitment activities to the end of study activities, up to 100 weeks.
Feasibility: Tolerability of Repeated VR use and Physiologic Monitoring
Proportion of participants able to complete repeated VR tasks and physiologic monitoring without early discontinuation due to discomfort, cybersickness, or adverse symptoms.
Measured: Assessed each 8-hour in laboratory visit
Feasibility: Data Completeness and Quality
Proportion of planned VR task sessions and physiologic recordings successfully completed with usable data.
Measured: Through study completion, an average of 1 year
Secondary outcomes (14)
Instruction Re-Engagement During VR Tasks
Number of times participants revisit or request task instructions during construction-related VR tasks.
Measured: Assessed during each 8-hour in-laboratory visit.
Task Resumption Time Following Disruption
Time (seconds) required for participants to resume task engagement following an interruption or distraction during VR tasks.
Measured: Assessed during each 8-hour in-laboratory visit.
VR Task Completion Time
Time required to complete construction-related VR tasks.
Measured: Assessed during each 8-hour in-laboratory visit.
Movement Efficiency During VR Tasks
Movement efficiency metrics during VR tasks, including the number of movements required to manipulate objects or complete task objectives.
Measured: Assessed during each 8-hour in-laboratory visit.
Controller Interaction Metrics
Controller interaction characteristics during VR tasks, including grip engagement and input patterns.
Measured: Assessed during each 8-hour in-laboratory visit.
Gaze Behavior During VR Tasks
Gaze behavior during VR tasks assessed via eye tracking, including fixation duration and spatial distribution of gaze points.
Measured: Assessed during each 8-hour in-laboratory visit.
Subjective Sleepiness
The Karolinska Sleepiness Scale (KSS) with responses 1 (Extremely alert) to 10 (Extremely sleepy, can't keep awake) will assess subjective sleepiness
Measured: 4 Time Points during each 8-hour in-laboratory visit
Positive Affect
Positive affect assessed using the Positive Affect subscale of the Positive and Negative Affect Schedule (PANAS). The Positive Affect subscale consists of 10 items rated on a 5-point Likert scale (1 = very slightly or not at all to 5 = extremely), with total scores ranging from 10 to 50. Higher scores indicate greater positive affect.
Measured: Assessed at four time points during each 8-hour in-laboratory visit.
Negative Affect
Negative affect assessed using the Negative Affect subscale of the Positive and Negative Affect Schedule (PANAS). The Negative Affect subscale consists of 10 items rated on a 5-point Likert scale (1 = very slightly or not at all to 5 = extremely), with total scores ranging from 10 to 50. Higher scores indicate greater negative affect.
Measured: Assessed at four time points during each 8-hour in-laboratory visit.
Mood Disturbance
Mood disturbance assessed using the Profile of Mood States (POMS). The POMS evaluates multiple mood domains (e.g., tension-anxiety, depression-dejection, anger-hostility, vigor, fatigue, confusion). A Total Mood Disturbance (TMD) score is calculated by summing negative mood subscales and subtracting the vigor score. TMD scores typically range from approximately -20 to 100, depending on the version used. Higher scores indicate greater overall mood disturbance, while lower or negative scores indicate more favorable mood states.
Measured: Assessed at four time points during each 8-hour in-laboratory visit.
Parasympathetic activity
Assessed using the high frequency power (HF) of the HRV power spectrum (collected from cleaned ECG using Kubios) to estimate cardiac parasympathetic activity as modulated by respiratory sinus arrhythmia during the time of seated rest noted above (but first 5 minutes consistent with field standards).
Measured: Assessed during each 8-hour in-laboratory visit.
Systolic Blood Pressure
Will be measured beat-to-beat using a non-invasive device employing the volume-clamp method with hydrostatic correction with measures on alternating fingers every 15 min (NIBP).
Measured: Assessed during each 8-hour in-laboratory visit.
Diastolic Blood Pressure
Will be measured beat-to-beat using a non-invasive device employing the volume-clamp method with hydrostatic correction with measures on alternating fingers every 15 min (NIBP).
Measured: Assessed during each 8-hour in-laboratory visit.
Electrodermal activity
Continuously assessed using galvanic skin response (GSR) electrodes attached to a fully isolated low voltage amplifier (AD Instruments Ltd). GSR electrodes will be attached to the distal phalange of the index and middle fingers of the non-dominant hand via supplied Velcro tape.
Measured: Assessed during each 8-hour in-laboratory visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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
- Crossover
- Model description
- Participants will be randomized to participate in construction virtual reality tasks on visit 1 or visit 2.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole Bowles, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431970
- Sponsor's protocol ID
- STUDY00029690
- Acronym
- ACES
- Status last verified
- Jan 2026
- First submitted
- 3 Feb 2026
- Last updated
- 25 Feb 2026
- 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 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of VR Construction Simulations for Detecting Sleep-Related Impairments
- ClinicalTrials.gov ID
- NCT07431970
- Acronym / sponsor ID
- ACES / STUDY00029690
- Conditions
- Sleep
- Keywords
- Occupational Health, Construction, Sleep, Virtual Reality, Sleep Impairment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 25 Feb 2026 (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 goal of this study is to learn whether virtual reality (VR) construction tasks can detect performance changes associated with prior sleep, and to determine the extent to which these changes can be distinguished from interacting repetitively with VR itself.
Detailed description
After passing a physical assessment and psychological screen, up to 12 participants will be enrolled. Ahead of each 8-hour in-laboratory assessment, participants will be asked to participate in a 1-week at-home monitoring period while continuing with their regular sleep/wake schedule. During this at-home assessment participants will be asked to wear an ActiGraph to objectively assess sleep and complete daily sleep diaries and call into a time-stamped voice-mailbox when going to bed and getting out of bed to confirm sleep/wake times. Participants will be asked to refrain from any alcohol, substances, or intense physical activity during each 1-week at home monitoring period. Similarly, participants are asked to refrain from caffeine consumption 5h prior to the in lab. Participants will then participate in two 8-hour sessions in an in-laboratory setting with a 1-week washout period in-between each in-laboratory visit. The two 8-hour visits will be identical in schedule and instrumentation, differing only in whether VR tasks are administered. Order of visits will be randomized. At each visit, participants will arrive to the laboratory ~6h after their habitual waketime (determined from daily call-ins) and be hooked up for ECG and beat-by-beat blood pressure. They will wear an ActiGraph the entire in-laboratory visit. Participants will also be asked to complete the Karolinska Sleepiness Scale (KSS) questionnaire and the modified Positive Affect-Negative Affect Schedule (PANAS) and the Profile of Mood States (POMS) questionnaire. Finally, participants will be asked to complete construction virtual reality tasks using a virtual reality headset during each of the 4 time points at each visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized to participate in construction virtual reality tasks on visit 1 or visit 2.
| Arm | Type | Receives |
|---|---|---|
| Construction Virtual Reality Stress Challenges | Experimental | Other: Construction Virtual Reality Stress ChallengesParticipants will be randomly assigned to a laboratory visit that will contain construction virtual reality stress challenges. |
| No Construction Virtual Reality Stress Challenges | Experimental | Other: No Construction Virtual Reality Stress ChallengesParticipants will be randomly assigned to a laboratory visit that will not contain construction virtual reality stress challenges. |
Who may qualify
- Ages
- 21 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Fluent in English
- Tolerate virtual reality system
Key exclusion criteria (7 listed)
- Recent shiftwork
- Recent travel across time zones (>2 in last month)
- Underlying health conditions (high blood pressure, diabetes, cancer, heart attack, heart failure, angioplasty, heart surgery, etc.)
- Use of nicotine products such as tobacco or e-cigarettes
- Use of illicit drugs in the past year
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 |
|---|---|---|
| Construction Virtual Reality Stress ChallengesParticipants will be randomly assigned to a laboratory visit that will contain construction virtual reality stress challenges. | Other | Construction Virtual Reality Stress Challenges |
| No Construction Virtual Reality Stress ChallengesParticipants will be randomly assigned to a laboratory visit that will not contain construction virtual reality stress challenges. | Other | No Construction Virtual Reality Stress Challenges |
Primary outcome
Feasibility: Recruitment
Time frame: From first date of recruitment activities to last day of study activities, up to 100 weeks.
Number of eligible participants who enroll in the study.
Feasibility: Retention
Time frame: From start of recruitment activities to the end of study activities, up to 100 weeks.
Proportion of eligible participants who enroll and complete all scheduled study visits.
Feasibility: Tolerability of Repeated VR use and Physiologic Monitoring
Time frame: Assessed each 8-hour in laboratory visit
Proportion of participants able to complete repeated VR tasks and physiologic monitoring without early discontinuation due to discomfort, cybersickness, or adverse symptoms.
Feasibility: Data Completeness and Quality
Time frame: Through study completion, an average of 1 year
Proportion of planned VR task sessions and physiologic recordings successfully completed with usable data.
14 secondary outcomes
Instruction Re-Engagement During VR Tasks
Time frame: Assessed during each 8-hour in-laboratory visit.
Task Resumption Time Following Disruption
Time frame: Assessed during each 8-hour in-laboratory visit.
VR Task Completion Time
Time frame: Assessed during each 8-hour in-laboratory visit.
Movement Efficiency During VR Tasks
Time frame: Assessed during each 8-hour in-laboratory visit.
Controller Interaction Metrics
Time frame: Assessed during each 8-hour in-laboratory visit.
Gaze Behavior During VR Tasks
Time frame: Assessed during each 8-hour in-laboratory visit.
Subjective Sleepiness
Time frame: 4 Time Points during each 8-hour in-laboratory visit
Positive Affect
Time frame: Assessed at four time points during each 8-hour in-laboratory visit.
Negative Affect
Time frame: Assessed at four time points during each 8-hour in-laboratory visit.
Mood Disturbance
Time frame: Assessed at four time points during each 8-hour in-laboratory visit.
Parasympathetic activity
Time frame: Assessed during each 8-hour in-laboratory visit.
Systolic Blood Pressure
Time frame: Assessed during each 8-hour in-laboratory visit.
Diastolic Blood Pressure
Time frame: Assessed during each 8-hour in-laboratory visit.
Electrodermal activity
Time frame: Assessed during each 8-hour in-laboratory visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Construction Virtual Reality Stress Challenges and No Construction Virtual Reality Stress Challenges in people with Sleep, run by Oregon Health and Science University 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 2 inclusion and 7 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: opening soon, as of the sponsor's last update on 25 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole P Bowles, PhD (503-494-2541, bowlesn@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Recruitment (time frame: From first date of recruitment activities to last day of study activities, up to 100 weeks.). 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 25 Feb 2026.