Kalogon Pilot Fatigue and Comfort Study

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

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:

1. Does the Kalogon AF Prototype seat cushion improve pilot comfort compared to the standard seat cushion?
2. 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.

Study Overview

• Status: Completed
• Conditions: B52 Pilot Fatigue and Comfort
• Intervention / Treatment: Device: Kalogon AF Prototype Smart Cushion; Device: Standard Seat Cushion from Air Force

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Melbourne, Florida, United States, 32901
      • Kalogon Headquarters

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 22 Healthy Volunteers; 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; 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.; Other Names: Kalogon; Device: Standard Seat Cushion from Air Force; 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.; Other Names: Standard

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Kalogon
• Collaborators: United States Department of Defense; EC Service
• Investigators: Principal Investigator: Evan Call, MS, CSM-NRM, EC Service

Publications and helpful links

General Publications

• 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.
• 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.
• Shen W, Parsons KC. Validity and reliability of rating scales for seated pressure discomfort. International Journal of Industrial Ergonomics. 1997; 20(6), 441-461

Helpful Links

• FAA Medications List
• Air Force Medical Disqualifications
• Air Force Weight Requirements

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Actual): October 28, 2023
• Study Completion (Actual): October 28, 2023

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: October 30, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Fatigue; Comfort; B52 Pilot; US Air Force; Dynamic cushion
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: 605.019 rev 3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: At the conclusion of the study, the protocol and report will be made available to the Air Force Research Lab (AFRL) for their review.
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: All data will be deidentified and will be available to designated personnel at the AFRL
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No