Feasibility of VR Construction Simulations for Detecting Sleep-Related Impairments
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Feasibility: Recruitment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fluent in English
- •Tolerate virtual reality system
排除标准
- •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)
研究组 & 干预措施
Construction Virtual Reality Stress Challenges
Participants will be randomly assigned to a laboratory visit that will contain construction virtual reality stress challenges.
干预措施: Construction Virtual Reality Stress Challenges (Other)
No Construction Virtual Reality Stress Challenges
Participants will be randomly assigned to a laboratory visit that will not contain construction virtual reality stress challenges.
干预措施: No Construction Virtual Reality Stress Challenges (Other)
结局指标
主要结局
Feasibility: Recruitment
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Through study completion, an average of 1 year
Proportion of planned VR task sessions and physiologic recordings successfully completed with usable data.
次要结局
- Instruction Re-Engagement During VR Tasks(Assessed during each 8-hour in-laboratory visit.)
- Task Resumption Time Following Disruption(Assessed during each 8-hour in-laboratory visit.)
- VR Task Completion Time(Assessed during each 8-hour in-laboratory visit.)
- Movement Efficiency During VR Tasks(Assessed during each 8-hour in-laboratory visit.)
- Controller Interaction Metrics(Assessed during each 8-hour in-laboratory visit.)
- Gaze Behavior During VR Tasks(Assessed during each 8-hour in-laboratory visit.)
- Subjective Sleepiness(4 Time Points during each 8-hour in-laboratory visit)
- Positive Affect(Assessed at four time points during each 8-hour in-laboratory visit.)
- Negative Affect(Assessed at four time points during each 8-hour in-laboratory visit.)
- Mood Disturbance(Assessed at four time points during each 8-hour in-laboratory visit.)
- Parasympathetic activity(Assessed during each 8-hour in-laboratory visit.)
- Systolic Blood Pressure(Assessed during each 8-hour in-laboratory visit.)
- Diastolic Blood Pressure(Assessed during each 8-hour in-laboratory visit.)
- Electrodermal activity(Assessed during each 8-hour in-laboratory visit.)
研究者
Nicole Bowles
Assistant Professor
Oregon Health and Science University