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| Name | Class |
|---|---|
| EC Service | INDUSTRY |
| United States Department of Defense | FED |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 22 Healthy Volunteers | Experimental | Each of the 22 volunteers will participate in a trial with both of the seat cushions. The test order is randomized. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kalogon AF Prototype Smart Cushion | Device | 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evan Call, MS, CSM-NRM | EC Service | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kalogon Headquarters | Melbourne | Florida | 32901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29198969 | Background | Arsintescu L, Kato KH, Cravalho PF, Feick NH, Stone LS, Flynn-Evans EE. Validation of a touchscreen psychomotor vigilance task. Accid Anal Prev. 2019 May;126:173-176. doi: 10.1016/j.aap.2017.11.041. Epub 2017 Dec 2. | |
| 30642520 | Background | Vanacore A, Lanzotti A, Percuoco C, Capasso A, Vitolo B. Design and analysis of comparative experiments to assess the (dis-)comfort of aircraft seating. Appl Ergon. 2019 Apr;76:155-163. doi: 10.1016/j.apergo.2018.12.012. Epub 2019 Jan 8. |
| Label | URL |
|---|---|
| FAA Medications List | View source |
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At the conclusion of the study, the protocol and report will be made available to the Air Force Research Lab (AFRL) for their review.
The CSR will be made available no later than December 15, 2023. The ICF, SAP, and study protocol were provided to them prior to the initiation of the study.
All data will be deidentified and will be available to designated personnel at the AFRL
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 31, 2023 | Dec 7, 2023 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 13, 2023 | Dec 7, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012015 | Reference Standards |
| ID | Term |
|---|---|
| D014894 | Weights and Measures |
| D008919 | Investigative Techniques |
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| Standard Seat Cushion from Air Force | Device | 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. |
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| Background | Shen W, Parsons KC. Validity and reliability of rating scales for seated pressure discomfort. International Journal of Industrial Ergonomics. 1997; 20(6), 441-461 |
| Air Force Weight Requirements | View source |