Flight Crew Alertness and Sleep Relative to Timing of In-Flight Rest Periods in Long-Haul Flights.

BACKGROUND: In-flight breaks are used during augmented long-haul flight operations, allowing pilots a sleep opportunity. The U.S. Federal Aviation Administration duty and rest regulations restrict the pilot flying the landing to using the third rest break. It is unclear how effective these restrictions are on pilots ability to obtain sleep. We hypothesized there would be no difference in self-reported sleep, alertness, and fatigue between pilots taking the second vs. third rest breaks.METHODS: Pilots flying augmented operations in two U.S.-based commercial airlines were eligible for the study. Volunteers completed a survey at top-of-descent (TOD), including self-reported in-flight sleep duration, and Samn-Perelli fatigue and Karolinska Sleepiness Scale ratings. We compared the second to third rest break using noninferiority analysis. The influence of time of day (home-base time; HBT) was evaluated in 4-h blocks using repeated measures ANOVA.RESULTS: From 787 flights 500 pilots provided complete data. The second rest break was noninferior to the third break for self-reported sleep duration (1.5 0.7 h vs. 1.4 0.7 h), fatigue (2.0 1.0 vs. 2.9 1.3), and sleepiness (2.6 1.4 vs. 3.8 1.8) at TOD for landing pilots. Measures of sleep duration, fatigue, and sleepiness were influenced by HBT circadian time of day.DISCUSSION: We conclude that self-reported in-flight sleep, fatigue, and sleepiness from landing pilots taking the second in-flight rest break are equivalent to or better than pilots taking the third break. Our findings support providing pilots with choice in taking the second or third in-flight rest break during augmented operations.Gregory KB, Soriano-Smith RN, Lamp ACM, Hilditch CJ, Rempe MJ, Flynn-Evans EE, Belenky GL. Flight crew alertness and sleep relative to timing of in-flight rest periods in long-haul flights. Aerosp Med Hum Perform. 2021; 92(2):8391.

Delta: The Value That Matters in Fatigue Risk Management.

INTRODUCTION: Noninferiority or equivalence testing are often used when comparing a novel pharmaceutical, operation, or procedure to the current standard designated as safe. Noninferiority and equivalence testing require estimates of a metric called delta: the margin of meaningful difference. Inappropriate delta margins can lead to invalid conclusions, thereby creating uncertainty about a studys scientific credibility. We recommend that a working group be convened with the following goals: 1) to evaluate delta values currently in use in aviation; 2) to determine if it is possible to develop a systematic, evidence-based, and replicable process to derive delta values based on statistical properties from population data, rather than a mixture of evidence- and opinion-based processes; and 3) based on the findings of the second goal, update the current delta values in use in aviation. This working group should include, at a minimum, government agencies and other key stakeholders using these values within operational settings.Lamp ACM, Rempe MJ, Belenky GL. Delta: the value that matters in fatigue risk management. Aerosp Med Hum Perform. 2021; 92(2):127128.

The rate of absorption and relative bioavailability of caffeine administered in chewing gum versus capsules to normal healthy volunteers.

OBJECTIVE: The purpose of this study was to evaluate the rate of absorption and relative bioavailability of caffeine from a Stay Alert chewing gum and capsule formulation. METHODS: This was a double blind, parallel, randomized, seven treatment study. The treatment groups were: 50, 100, and 200 mg gum, 50, 100, and 200 mg capsule, and a placebo. Subjects consisted of 84 (n=12 per group); healthy, non-smoking, males who had abstained from caffeine ingestion for at least 20 h prior to dosing and were randomly assigned to the treatment groups. Blood samples were collected pre-dose and at 5, 15, 25, 35, 45, 55, 65, 90 min and 2, 3, 4, 6, 8, 12, 16 and 29 h post administration. Plasma caffeine levels were analyzed by a validated UV-HPLC method. RESULTS: Mean Tmax for the gum groups ranged from 44.2 to 80.4 min as compared with 84.0-120.0 min for the capsule groups. The Tmax, for the pooled data was significantly lower (P<0.05) for the gum groups as compared with the capsule groups. Differences in Tmax were significant for the 200 mg capsule versus 200 mg gum (P<0.05). The mean ka values for the gum group ranged from 3.21 to 3.96 h-1 and for the capsule groups ranged from 1.29 to 2.36 h-1. Relative bioavailability of the gum formulation after the 50, 100 and 200 mg dose was 64, 74 and 77%, respectively. When normalized to the total drug released from the gum (85%), the relative bioavailability of the 50, 100 and 200 mg dose were 75, 87, and 90%, respectively. No statistical differences were found for Cmax and AUCinf for comparisons of the gum and capsule formulations at each dose. Within each dose level, there were no significant formulation related differences in Cmax. No significant differences were observed in the elimination of caffeine after the gum or capsule. CONCLUSIONS: The results suggest that the rate of drug absorption from the gum formulation was significantly faster and may indicate absorption via the buccal mucosa. In addition, for the 100 and 200 mg groups, the gum and capsule formulations provide near comparable amounts of caffeine to the systemic circulation. These findings suggest that there may be an earlier onset of pharmacological effects of caffeine delivered as the gum formulation, which is advantageous in situations where the rapid reversal of alertness and performance deficits resulting from sleep loss is desirable.