Kalogon Pilot Fatigue and Comfort Study

Not Applicable

Completed

• Conditions: B52 Pilot Fatigue and Comfort
• Interventions: Device: Kalogon AF Prototype Smart Cushion; Device: Standard Seat Cushion from Air Force

• Registration Number: NCT06116708
• Lead Sponsor: Kalogon

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:

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.

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 Timeline

• Study Start: 2023-10-10
• Study First Submitted: 2023-10-25
• Primary Completion: 2023-10-28
• Study Completion: 2023-10-28
• Study First Submitted QC: 2023-10-30
• Study First Posted: 2023-11-03
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-26
• Last Update Posted: 2024-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
22 Healthy Volunteers	Kalogon AF Prototype Smart Cushion	Each of the 22 volunteers will participate in a trial with both of the seat cushions. The test order is randomized.
22 Healthy Volunteers	Standard Seat Cushion from Air Force	Each of the 22 volunteers will participate in a trial with both of the seat cushions. The test order is randomized.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Kalogon Headquarters; 🇺🇸 Melbourne, Florida, United States