Kalogon Pilot Fatigue and Comfort Study

Sponsor

Kalogon (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06116708

Collaborator

EC Service (Industry), United States Department of Defense (U.S. Fed)

Enrollment

Location

Arm

1.8

Anticipated Duration (Months)

12.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
B52 Pilot Fatigue and Comfort	Device: Kalogon AF Prototype Smart Cushion Device: Standard Seat Cushion from Air Force	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Oct 10, 2023

Anticipated Primary Completion Date :

Oct 27, 2023

Anticipated Study Completion Date :

Dec 4, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Comfort [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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