An interventional study of Construction Virtual Reality Stress Challenges and No Construction Virtual Reality Stress Challenges in Sleep, sponsored by Oregon Health and Science University. Not yet recruiting at 1 site in United States. Open to participants aged 21 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-25.
Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Basic science
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.
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.
Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will be randomly assigned to a laboratory visit that will contain construction virtual reality stress challenges.
Other: Construction Virtual Reality Stress Challenges
Participants will be randomly assigned to a laboratory visit that will not contain construction virtual reality stress challenges.
Other: No 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 not contain construction virtual reality stress challenges.
Feasibility: Recruitment
Number of eligible participants who enroll in the study.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 1 year
Instruction Re-Engagement During VR Tasks
Number of times participants revisit or request task instructions during construction-related VR tasks.
Time frame: 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.
Time frame: Assessed during each 8-hour in-laboratory visit.
VR Task Completion Time
Time required to complete construction-related VR tasks.
Time frame: 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.
Time frame: Assessed during each 8-hour in-laboratory visit.
Controller Interaction Metrics
Controller interaction characteristics during VR tasks, including grip engagement and input patterns.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Assessed during each 8-hour in-laboratory visit.
Plan to share: No
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Oregon Health and Science University