Kalogon Pilot Fatigue and Comfort Study

Kalogon

Status: Completed

Conditions: B52 Pilot Fatigue and Comfort

Treatments: Device: Kalogon AF Prototype Smart Cushion; Device: Standard Seat Cushion from Air Force

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT06116708

605.019 rev 3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

22 Healthy Volunteers

Experimental group

Description:

Each of the 22 volunteers will participate in a trial with both of the seat cushions. The test order is randomized.

Treatment:

Device: Standard Seat Cushion from Air Force

Device: Kalogon AF Prototype Smart Cushion