Oregon Health and Science University
Portland, Oregon, 97239, United States
Location contact
Nicole P Bowles, PhD
CONTACT
Nicole P Bowles, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07431970
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.
Trial opening soon.
Get Notified21 year–49 year
All sexes
Interventional
Not applicable
Portland, Oregon, 97239, United States
Nicole P Bowles, PhD
CONTACT
Nicole P Bowles, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Time frame: Through study completion, an average of 1 year
Proportion of planned VR task sessions and physiologic recordings successfully completed with usable data.
Time frame: Assessed during each 8-hour in-laboratory visit.
Number of times participants revisit or request task instructions during construction-related VR tasks.
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.
Time frame: Assessed during each 8-hour in-laboratory visit.
Time required to complete construction-related 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.
Time frame: Assessed during each 8-hour in-laboratory visit.
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 assessed via eye tracking, including fixation duration and spatial distribution of gaze points.
Time frame: 4 Time Points during each 8-hour in-laboratory visit
The Karolinska Sleepiness Scale (KSS) with responses 1 (Extremely alert) to 10 (Extremely sleepy, can't keep awake) will assess subjective sleepiness
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.
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.
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.
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).
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).
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).
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.
Contact information is provided by the study sponsor or research team.
Oregon Health and Science University
Other
Feasibility of VR Construction Simulations for Detecting Sleep-Related Impairments
Acronym: ACES
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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