Assessing Construction Execution Under Sleep Impairment
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Construction Virtual Reality Stress Challenges, No Construction Virtual Reality Stress Challenges.
- Кому может быть актуально
- Состояния в реестре: Sleep. Базовые параметры: 21 лет — 49 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Feasibility of VR Construction Simulations for Detecting Sleep-Related Impairments
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое Construction Virtual Reality Stress Challenges
Participants will be randomly assigned to a laboratory visit that will contain construction virtual reality stress challenges. - Другое No Construction Virtual Reality Stress Challenges
Participants will be randomly assigned to a laboratory visit that will not contain construction virtual reality stress challenges.
Первичные конечные точки
- Feasibility: Recruitment [Срок оценки: From first date of recruitment activities to last day of study activities, up to 100 weeks.]
- Feasibility: Retention [Срок оценки: From start of recruitment activities to the end of study activities, up to 100 weeks.]
- Feasibility: Tolerability of Repeated VR use and Physiologic Monitoring [Срок оценки: Assessed each 8-hour in laboratory visit]
- Feasibility: Data Completeness and Quality [Срок оценки: Through study completion, an average of 1 year]
Вторичные конечные точки (12)
- Instruction Re-Engagement During VR Tasks [Срок оценки: Assessed during each 8-hour in-laboratory visit.]
- Task Resumption Time Following Disruption [Срок оценки: Assessed during each 8-hour in-laboratory visit.]
- VR Task Completion Time [Срок оценки: Assessed during each 8-hour in-laboratory visit.]
- Movement Efficiency During VR Tasks [Срок оценки: Assessed during each 8-hour in-laboratory visit.]
- Controller Interaction Metrics [Срок оценки: Assessed during each 8-hour in-laboratory visit.]
- Gaze Behavior During VR Tasks [Срок оценки: Assessed during each 8-hour in-laboratory visit.]
- Subjective Sleepiness [Срок оценки: 4 Time Points during each 8-hour in-laboratory visit]
- Positive Affect [Срок оценки: Assessed at four time points during each 8-hour in-laboratory visit.]
- Negative Affect [Срок оценки: Assessed at four time points during each 8-hour in-laboratory visit.]
- Mood Disturbance [Срок оценки: Assessed at four time points during each 8-hour in-laboratory visit.]
- Parasympathetic activity [Срок оценки: Assessed during each 8-hour in-laboratory visit.]
- Systolic Blood Pressure [Срок оценки: Assessed during each 8-hour in-laboratory visit.]
Критерии участия
Критерии включения
- Fluent in English
- Tolerate virtual reality system
Критерии исключения
- 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)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Простое слепое
- Основная цель
- Фундаментальное исследование
Центры проведения
США · 1 центр
- Oregon Health and Science University — Portland
Идентификаторы
NCT: NCT07431970 · STUDY00029690