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OpenTrials
Completed

NCT Number: NCT06116708

Kalogon 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.

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Key information

Conditions

B52 Pilot Fatigue and Comfort Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kalogon Headquarters

Melbourne, Florida, 32901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Kalogon

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.

Other names: Standard

Primary outcomes

  1. Comfort

    Time frame: 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.

  2. Fatigue

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kalogon

Industry

Collaborators

  • EC Service
  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 3, 2023
Registry last updated
Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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