Effect of the Kalogon AF Prototype Smart Cushion on B52 Pilot Fatigue and Comfort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Kalogon
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Comfort
研究概览
简要总结
The goal of this experimental study is to compare 2 different seat cushions in B52 cockpit seats to see if they affect pilot fatigue and comfort. The main questions it aims to answer are:
- Does the Kalogon AF Prototype seat cushion improve pilot comfort compared to the standard seat cushion?
- Does the Kalogon AF Prototype seat cushion reduce pilot fatigue compared to the standard cushion?
Participants will spend 8 hours in a simulated cockpit playing a flight simulator. They will fill out multiple questionnaires and take 2 attention/reaction time tests throughout the 8-hours.
详细描述
Participants will be screened for eligibility and if they qualify will be asked to provide informed consent and sign a photo release. Participants will be asked to avoid caffeine consumption on the day of testing, wear comfortable clothing with no back pockets on the pants/shorts, and bring food and water for them to consume during testing.
Once informed consent is given, they will be measured and weighed. They will then be given a flight suit to wear. Once they are in the flight suit, the first 5-minute Psychomotor Vigilance Task test (PVT) will be administered. Once completed, the participant will be strapped into the pilot seat.
Once the participant is properly secured to the pilot seat, the 8-hour timer will be started and the first Subjective Fatigue Survey will be administered. Once the questionnaire is completed they will begin playing the flight simulator. Participants will be encouraged to minimize bathroom breaks and will be given specific times to eat. At the 4-hour mark, the second Subjective Fatigue Survey will be administered. At the end of the 8 hours, a second PVT will be administered, followed by the final Subjective Fatigue Survey.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed Informed Consent
- •18 to 35 years old
- •Ambulatory
- •Able to sit for up to 12 hours with minimal breaks
- •Able to follow instructions in English
排除标准
- •Weight <91 lbs or > 250 lbs
- •Travel across time zones in the last 7 days
- •History of:
- •Chronic pain
- •Asthma or other bronchospasm diagnoses
- •Abnormalities of the heart valves, major vessels, heart rate or rhythm, any condition leading to poor circulation, increased risk of blood clots
- •Chronic disease of abdominal organs including hepatitis and inflammatory bowel disease
- •Un-united fractures, instability of a major joint, retained orthopedic fixation devices, severe scoliosis, or disorder of the skeletal muscles
- •Psoriasis
- •Psychosis, schizophrenia, or other severe mental health disorder
- •Seizure disorders
- •Sleeping disorders
- •Taking any of the following medications:
- •Muscle relaxants
- •Anticholinergics
- •Sedating antihistamines
- •Anti-psychotics
结局指标
主要结局
Comfort
时间窗: Beginning of trial (T0), 4 hours into the trial (T1), and at the end of the trial (T2), 8 hours after T0.
The subjective measure of the amount of discomfort and comfort that a participant experiences from sitting on the cushions. This outcome is evaluated using a Subjective Fatigue Survey that has 2 parts. The first part is a 35 question Discomfort Assessment that utilizes a labeled body map to allow volunteers to rate their level of discomfort in each body zone. The second part of the Subjective Fatigue Survey is a 13 question Comfort Assessment that contains 13 statements on the topic of comfort that volunteers indicate how much they agree with that statement using an 11-point Likert scale.
Fatigue
时间窗: Beginning of the trial (T0) and at the end (T2), 8 hours apart.
A psychomotor vigilance task test is utilized to measure fatigue through changes in response time.
次要结局
未报告次要终点