Clinical trial NCT06116708: Kalogon Pilot Fatigue and Comfort Study
Official title: Effect of the Kalogon AF Prototype Smart Cushion on B52 Pilot Fatigue and Comfort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: B52 Pilot Fatigue and Comfort
Keywords: B52 Pilot
US Air Force
Comfort
Fatigue
Dynamic cushion
Lead sponsor: Kalogon
Sponsor class: INDUSTRY
Collaborators: name: EC Service
name: United States Department of Defense
First posted: 2023-11-03
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comfort
timeFrame: Beginning of trial (T0), 4 hours into the trial (T1), and at the end of the trial (T2), 8 hours after T0.
measure: Fatigue
timeFrame: Beginning of the trial (T0) and at the end (T2), 8 hours apart.
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: United States
facility: Kalogon Headquarters
state: Florida
Study officials:
affiliation: EC Service
name: Evan Call, MS, CSM-NRM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Shen W, Parsons KC. Validity and reliability of rating scales for seated pressure discomfort. International Journal of Industrial Ergonomics. 1997; 20(6), 441-461