Sustaining Aviator Performance During Extended Operational Flight
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Response to emergency
研究概览
简要总结
Future aviation operations are anticipated to change as advances in technology enable automation of more tasks. Development of new platforms under the Future Vertical Lift program are also anticipated to change the nature of missions as they are being designed to cover further distances. Longer duration flights coupled with greater automated features are expected to shift the role of the aviator, resulting in an increased need for attention maintenance, which creates potential problems related to performance. To offset the likelihood of performance decrements related to the need to sustain attention, we propose examining the use of transcranial electrical current stimulation. In the present study, we will evaluate whether delivery of stimulation prior to or during the task enables sustainment of attention and thereby reduces performance decrements as measured through primary flight tasks and a secondary attentional task. Further, we will evaluate whether stimulation enhances the ability to respond to an unexpected emergency toward the end of the flight.
详细描述
Volunteers will first schedule an appointment to complete informed consent, screening procedures and meet with study physician. After eligibility is verified, volunteers will complete baseline assessments. At the completion of baseline assessments volunteers will be scheduled for their return visits and will be given their actiwatch. Scheduling will occur such that there is at least 16 hours' time between baseline assessments and their first treatment visit, whereas treatment visits will be scheduled such that there is at least 48 hours between visits. Stimulation will be counterbalanced with at least 48 hours between deliveries to allow for a washout period (Nitsche & Paulus, 2001). Scheduling will be done such that individual participants are always scheduled at the same time of day to control for any effects of circadian rhythm and individual differences.
Visit 1: Test scheduling, informed consent, screening procedures and baseline assessments.
During this visit, subjects will be informed that they should have 8 hours of sleep the night before each testing session, with a minimum of 6 accepted for participation (confirmed by an actiwatch and self-report). A minimum of 6 hours will be accepted to avoid potential loss of subjects who are not able to obtain 8 hours. However, 8 hours will be stressed to encourage subjects to be well rested prior to the testing days. They will also be instructed to refrain from taking over the counter medications which may induce drowsiness throughout the duration of the study, and refrain from the use of any stimulants including caffeine for a minimum of 16 hours prior to study participation, avoid alcohol use for a minimum of 24 hours prior to participation, and avoid the use of nicotine for a minimum of 2 hours prior to the study. These are requested to obtain clean physiological recordings (e.g., Gilbert, Dibb, Plath, & Hiyane, 2000 [caffeine, nicotine]; Kähkӧnen, Wilenius, Nikulin, Ollikainen, & Ilmoniemi, 2003 [alcohol]). If the participant reports use of a stimulant, medication inducing drowsiness, nicotine, alcohol, or the actiwatch indicates less than 6 hours of rest, the participant will be released from the study for that day and asked to reschedule. In the event that the actiwatch fails, confirmation will rely on self-report and be recorded within the study log.
Following informed consent, subjects will complete a medical history questionnaire with a study physician that includes caffeine consumption habits to determine any possible side effects due to caffeine withdrawal. A member of the research team will measure and record the subject's vital signs (temperature, respiration rate, blood pressure, pulse, and oxygen saturation) on the medical history questionnaire. The study physician will review the medical history questionnaire and vital signs to make a final determination regarding eligibility. In addition to determining eligibility, the study physician or medical practitioner will discuss with the subject regular caffeine consumption habit and whether the subject is likely to experience any negative side effects associated with caffeine withdrawal (e.g., headache). If determined to be eligible by the study physician, subjects will then be enrolled in the study, complete the volunteer registry database form, receive the actiwatch and be provided verbal instructions on its use and be given a handout of participation guidelines. After receiving the actiwatch and guidelines, the subject will be offered the opportunity for stimulation familiarization. This will entail applying the stimulation at the prescribed intensity (2 mA) for a duration of 5 minutes, with the anode at F3 and cathode on the contralateral bicep (right arm). The purpose of this will be to allow the subject to experience what the stimulation feels like so that they know what to expect for the stimulation days. After stimulation has been applied, the electrodes will be removed and the subjects will complete the following questionnaires: demographic questionnaire, Morningness-Eveningness Questionnaire (MEQ) , Adult ADHD Self Report Scale (ASRS), Sleep Timing Questionnaire (STQ), Beck Depression Inventory (BDI), Shipley's Institute of Living Scale (SILS), Convergence Insufficiency Symptom Survey (CISS), Samn-Perelli Fatigue Scale, Short Stress State Questionnaire (SSSQ), Behavioral Inhibition / Avoidance Scales (BIS/BAS), Karolinska Sleepiness Scale (KSS), and Profile of Mood States - Short Form (POMS-SF). The subject will next complete a baseline session of the Rapid Visual Information Processing Task (RVIP) and Conners' Continuous Performance Task (CPT). Following completion of questionnaires, the electroencephalogram will be placed on the subjects and baseline measurements will be taken, which is a series of three computerized tasks provided by Advanced Brain Monitoring (ABM Tasks) which will be used for baseline, and pre- / post-stimulation EEG measurements. Subjects will then meet with the research pilot who will go over the flight tasks required of this study and escort the subject into the simulator for familiarization and baseline flight performance data collection. During the familiarization flight, the research pilot will ensure the subject is able to meet prescribed flight standards such as maintain specified headings, airspeeds and altitudes with minimal input/prompts, which will be recorded on the flight standards sheet. The baseline flight will consist of a scenario similar to, but not exact, as the scenarios that will be performed on treatment days. Baseline performance and EEG will be recorded and archived for analyses/interpretation. Subjects will be released at this point for the day.
Visits 2-3: tDCS stimulation test sessions.
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
- 18 Years 至 40 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Must be a male 18 (Active Duty) or 19 (National Guard, Reservist) to 40 years old.
- •Must be a rated rotary-wing aviator with at least 200 hours of total flight experience, and have flown (aircraft or simulator) within the past 6 months, assessed by self-report.
- •Must have a current DD-2292 (up-slip indicating clear for flight duties). Subjects will self-report this on the medical history questionnaire (Appendix A).
- •Must have obtained at minimum 6 hours of sleep prior to data collection, as assessed by actigraphy data and self-report.
- •Must have refrained from consumption of caffeine and medications that cause drowsiness, 16 hours, nicotine, 2 hours, and alcohol, 24 hours, prior to the study, assessed by self-report.
排除标准
- •Not having a current DD-
- •The following medically-related exclusionary criteria will be used, as assessed and verified by the study physician (in addition to possessing a DD-2992):
- •Currently taking medications which induce drowsiness, such as over-the-counter antihistamines. Any self-medication will be assessed through self-report
- •No current medical conditions or medications affecting cognitive function or attention.
- •Any history of any attention deficit condition requiring medication.
- •Any history of psychological/psychiatric disorder.
- •Any history of seizures, migraines, or neurological disorders.
- •History of a head injury involving loss of consciousness.
- •Any metal implanted within the head (e.g., shrapnel, surgical clips) or any implanted devices (e.g., cardiac pacemaker, brain stimulator, hydrocephalic shunt).
- •Skin condition on the scalp, such as psoriasis or eczema, or wounds on the head.
- •Currently receiving hormonal therapy treatments.
- •Potential for caffeine withdrawal symptoms that will impede cognitive testing.
结局指标
主要结局
Response to emergency
时间窗: 1 - 5 min
Simulated emergency that requires response during flight.
Physiological response
时间窗: 90 min
EEG recording before and after stimulation.
Continuous Performance Task
时间窗: 14 min
Cognitive function - sustained attention The continuous performance task (Conners \& Sitarenios, 2011) is a well validated measure of sustained attention and response inhibition. In this task, subjects are presented with a series of letters and are instructed to respond when they see any letter except for the letter X. Subjects are presented with 360 trials with varied intervals of 1, 2, and 4 seconds. Total time to complete this task is 14 minutes.
Flight performance - primary task
时间窗: 90 min
Simulated flight 90 min simulated flight scenario in a UH60 simulator.
Rapid Visual Information Processing Task
时间窗: 7 min
Cognitive function - sustained attention The RVIP is a well-validated measure of sustained attention (Bakan, 1959). In each trial, subjects are presented with a sequence of digits and must detect "target" sequences within those presented. The target sequence is an even-odd-even string of numbers. When participants detect this string, they press the spacebar as quickly as possible. Difficulty is manipulated by changing the speed at which the numbers are presented (1 vs. 2 seconds).
Flight performance - secondary task
时间窗: 90 min
Simulated flight with visual secondary task A visual task presented during the flight requiring monitoring.
次要结局
- Short Stress State Questionnaire(2 min)
- Flight experience(10 min)
- Behavioral Scales Behavioral Inhibition / Avoidance Scale(10 min)
- Samn-Perelli Fatigue Scale(1 min)
- Boredom Proneness Scale(5 min)
- 40 Mini-Marker Personality Scale(10 min)
