Kalogon Pilot Fatigue and Comfort Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of the Kalogon AF Prototype Smart Cushion on B52 Pilot Fatigue and Comfort Study

Conditions
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B52 Pilot Fatigue and Comfort

Intervention / Treatment
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* Device: Kalogon AF Prototype Smart Cushion
* Device: Standard Seat Cushion from Air Force


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Weight <91 lbs or > 250 lbs Pregnant 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: Opiates Muscle relaxants Anticholinergics Sedating antihistamines Anti-psychotics

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 22 Healthy Volunteers<br>Each of the 22 volunteers will participate in a trial with both of the seat cushions. The test order is randomized. | Device: Kalogon AF Prototype Smart Cushion<br>* The Kalogon cushion is a dynamic smart cushion that utilizes a combination of foam and 5 adjustable air cells to intelligently redistribute weight and increase comfort for users. The air cells are used to modulate interface pressures and adjust where support or pressure reductions are provided based on input from the controller's pressure sensing system.<br>* Other names: Kalogon;Device: Standard Seat Cushion from Air Force<br>* This is the standard seat cushion that was provided by the United States Air Force to use for this study. It is a high-density, molded polyurethane foam.<br>* Other names: Standard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort | 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. | Beginning of trial (T0), 4 hours into the trial (T1), and at the end of the trial (T2), 8 hours after T0. | 
| Fatigue | A psychomotor vigilance task test is utilized to measure fatigue through changes in response time. | Beginning of the trial (T0) and at the end (T2), 8 hours apart. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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B52 Pilot, US Air Force, Comfort, Fatigue, Dynamic cushion