B52 Pilot Fatigue and ComfortNCT06116708
Kalogon Pilot Fatigue and Comfort Study
A study testing Kalogon AF Prototype Smart Cushion and Standard Seat Cushion from Air Force in people with B52 Pilot Fatigue and Comfort, run by Kalogon at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- B52 Pilot Fatigue and Comfort
- What is being tested?
- Kalogon AF Prototype Smart Cushion and Standard Seat Cushion from Air Force
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2023to 28 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Kalogon AF Prototype Smart Cushion on B52 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:
- 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.
Read the 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.
- Conditions
- B52 Pilot Fatigue and Comfort
- Being tested
- Kalogon AF Prototype Smart Cushion, Standard Seat Cushion from Air Force
- Keywords
- B52 Pilot, US Air Force, Comfort, Fatigue, Dynamic cushion
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kalogon AF Prototype Smart CushionDevice
Also called Kalogon
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.
Standard Seat Cushion from Air ForceDevice
Also called Standard
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.
| Study group | Role | What they receive |
|---|---|---|
| 22 Healthy Volunteers | Experimental | Each of the 22 volunteers will participate in a trial with both of the seat cushions. The test order is randomized. Receives: Device: Kalogon AF Prototype Smart Cushion; Device: Standard Seat Cushion from Air Force |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort
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.
Measured: Beginning of trial (T0), 4 hours into the trial (T1), and at the end of the trial (T2), 8 hours after T0.
Fatigue
A psychomotor vigilance task test is utilized to measure fatigue through changes in response time.
Measured: Beginning of the trial (T0) and at the end (T2), 8 hours apart.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start10 Oct 2023
- Primary completion28 Oct 2023
- Study completion28 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for B52 Pilot Fatigue and ComfortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kalogon
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EC Service, United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Evan Call, MS, CSM-NRM, Principal investigator, EC Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116708
- Sponsor's protocol ID
- 605.019 rev 3
- Status last verified
- Dec 2023
- First submitted
- 25 Oct 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the conclusion of the study, the protocol and report will be made available to the Air Force Research Lab (AFRL) for their review.
Publications
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.
PubMed 29198969Vanacore 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.
PubMed 30642520Shen W, Parsons KC. Validity and reliability of rating scales for seated pressure discomfort. International Journal of Industrial Ergonomics. 1997; 20(6), 441-461
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Kalogon AF Prototype Smart Cushion on B52 Pilot Fatigue and Comfort Study
- ClinicalTrials.gov ID
- NCT06116708
- Acronym / sponsor ID
- 605.019 rev 3
- Conditions
- B52 Pilot Fatigue and Comfort
- Keywords
- B52 Pilot, US Air Force, Comfort, Fatigue, Dynamic cushion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- KalogonIndustry (pharma, biotech, devices)
- Collaborators
- EC Service, United States Department of Defense
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 28 Oct 2023 (actual)
- Study completion
- 28 Oct 2023 (actual)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 22 Healthy Volunteers | Experimental | Device: Kalogon AF Prototype Smart Cushion, Device: Standard Seat Cushion from Air ForceEach of the 22 volunteers will participate in a trial with both of the seat cushions. The test order is randomized. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- Weight <91 lbs or > 250 lbs
- Pregnant
- Travel across time zones in the last 7 days
- History of:
- Chronic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kalogon AF Prototype Smart CushionAlso: KalogonThe 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. | Device | 22 Healthy Volunteers |
| Standard Seat Cushion from Air ForceAlso: StandardThis 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. | Device | 22 Healthy Volunteers |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Background: PubMed 29198969Arsintescu 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.
- Background: PubMed 30642520Vanacore 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.
- BackgroundShen W, Parsons KC. Validity and reliability of rating scales for seated pressure discomfort. International Journal of Industrial Ergonomics. 1997; 20(6), 441-461
- FAA Medications ListLink provided by the sponsor.
- Air Force Weight RequirementsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. At the conclusion of the study, the protocol and report will be made available to the Air Force Research Lab (AFRL) for their review.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evan Call, MS, CSM-NRM principal investigator
EC Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kalogon AF Prototype Smart Cushion and Standard Seat Cushion from Air Force in people with B52 Pilot Fatigue and Comfort, run by Kalogon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06116708, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.