- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07431970
Assessing Construction Execution Under Sleep Impairment (ACES)
February 17, 2026 updated by: Nicole Bowles, Oregon Health and Science University
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.
Study Overview
Status
Not yet recruiting
Conditions
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 Type
Interventional
Enrollment (Estimated)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nicole P Bowles, PhD
- Phone Number: 503-494-2541
- Email: bowlesn@ohsu.edu
Study Locations
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health and Science University
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Contact:
- Nicole P Bowles, PhD
- Phone Number: 503-494-2541
- Email: bowlesn@ohsu.edu
-
Principal Investigator:
- Nicole P Bowles, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Fluent in English
- Tolerate virtual reality system
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Construction Virtual Reality Stress Challenges
Participants will be randomly assigned to a laboratory visit that will contain construction virtual reality stress challenges.
|
Participants will be randomly assigned to a laboratory visit that will contain construction virtual reality stress challenges.
|
|
Experimental: No Construction Virtual Reality Stress Challenges
Participants will be randomly assigned to a laboratory visit that will not contain construction virtual reality stress challenges.
|
Participants will be randomly assigned to a laboratory visit that will not contain construction virtual reality stress challenges.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From first date of recruitment activities to last day of study activities, up to 100 weeks.
|
|
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.
|
From start of recruitment activities to the end of study activities, up to 100 weeks.
|
|
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.
|
Assessed each 8-hour in laboratory visit
|
|
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.
|
Through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Instruction Re-Engagement During VR Tasks
Time Frame: Assessed during each 8-hour in-laboratory visit.
|
Number of times participants revisit or request task instructions during construction-related VR tasks.
|
Assessed during each 8-hour in-laboratory visit.
|
|
Task Resumption Time Following Disruption
Time Frame: Assessed during each 8-hour in-laboratory visit.
|
Time (seconds) required for participants to resume task engagement following an interruption or distraction during VR tasks.
|
Assessed during each 8-hour in-laboratory visit.
|
|
VR Task Completion Time
Time Frame: Assessed during each 8-hour in-laboratory visit.
|
Time required to complete construction-related VR tasks.
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Assessed during each 8-hour in-laboratory visit.
|
|
Movement Efficiency During VR Tasks
Time Frame: Assessed during each 8-hour in-laboratory visit.
|
Movement efficiency metrics during VR tasks, including the number of movements required to manipulate objects or complete task objectives.
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Assessed during each 8-hour in-laboratory visit.
|
|
Controller Interaction Metrics
Time Frame: Assessed during each 8-hour in-laboratory visit.
|
Controller interaction characteristics during VR tasks, including grip engagement and input patterns.
|
Assessed during each 8-hour in-laboratory visit.
|
|
Gaze Behavior During VR Tasks
Time Frame: Assessed during each 8-hour in-laboratory visit.
|
Gaze behavior during VR tasks assessed via eye tracking, including fixation duration and spatial distribution of gaze points.
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Assessed during each 8-hour in-laboratory visit.
|
|
Subjective Sleepiness
Time Frame: 4 Time Points during each 8-hour in-laboratory visit
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The Karolinska Sleepiness Scale (KSS) with responses 1 (Extremely alert) to 10 (Extremely sleepy, can't keep awake) will assess subjective sleepiness
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4 Time Points during each 8-hour in-laboratory visit
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Positive Affect
Time Frame: Assessed at four time points during each 8-hour in-laboratory visit.
|
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.
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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.
|
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.
|
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.
|
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.
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Assessed at four time points during each 8-hour in-laboratory visit.
|
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Parasympathetic activity
Time Frame: Assessed during each 8-hour in-laboratory visit.
|
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).
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Assessed during each 8-hour in-laboratory visit.
|
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Systolic Blood Pressure
Time Frame: Assessed during each 8-hour in-laboratory visit.
|
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).
|
Assessed during each 8-hour in-laboratory visit.
|
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Diastolic Blood Pressure
Time Frame: Assessed during each 8-hour in-laboratory visit.
|
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).
|
Assessed during each 8-hour in-laboratory visit.
|
|
Electrodermal activity
Time Frame: Assessed during each 8-hour in-laboratory visit.
|
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.
|
Assessed during each 8-hour in-laboratory visit.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2026
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Study Registration Dates
First Submitted
February 3, 2026
First Submitted That Met QC Criteria
February 17, 2026
First Posted (Actual)
February 25, 2026
Study Record Updates
Last Update Posted (Actual)
February 25, 2026
Last Update Submitted That Met QC Criteria
February 17, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00029690
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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