Intranasal Scopolamine for Motion Sickness.

INTRODUCTION: Rapid onset, noninjection methods are required to provide "as needed" therapy for motion sickness. Intranasal scopolamine (IN SCOP) is attractive because it can be fast acting and work when gastric motility is slowed. Intranasal administration can provide a time to maximal concentration (Tmax) of drugs (e.g., naloxone and midazolam) of 30 min or less. We evaluated the efficacy, pharmacodynamics, and pharmacokinetics of IN SCOP in a placebo-controlled, randomized, double-blind, dose-ranging study, and compared pharmacokinetic outcomes against other published results.METHODS: There were 18 healthy adult volunteers (10 M, 8F) who received placebo, low dose (0.2 mg), and high dose (0.4 mg) IN SCOP intranasally using a pump device and a gel formulation. Participants rode in an off-vertical axis rotation (OVAR) chair 1.25 h after dose administration and completed neurocognitive tests to evaluate secondary drug impacts. Pharmacokinetics (PK) and pharmacodynamics (PD) were assessed in eight subjects. PK data were compared to results from previously published studies.RESULTS: Low and high dose IN SCOP increased chair time significantly compared to placebo. No significant sleepiness or cognitive impairment was seen, likely due to the small sample size. Tmax was long for both dosages (High dose 75.0 ± 49.4 min, Low dose 61.9 ± 37.1 min), compared to other intranasally administered drugs and some previous studies with IN SCOP. Average Tmax was not superior to previously published values for dose-matched (0.4-0.5 mg), orally-delivered SCOP.DISCUSSION: IN SCOP has potential as a rapid administration route for relieving MS symptoms, but more work is needed to identify optimal intranasal formulation and dispensing methods.KEYWORDS: Motion sickness, pharmacokinetics, scopolamine, intranasal administration.Stankovic AS, Alvarenga DL, Daniels VRC, Simmons RG, Buckey JC, Putcha L. Intranasal scopolamine for motion sickness. Aerosp Med Hum Perform. 2019; 90(11):917-924.

Forehead-mounted reflectance oximetry for in-cockpit hypoxia early detection and warning.

INTRODUCTION: Effective hypoxia-related mishap prevention relies upon aircrew rapid recognition of hypoxia symptoms. The objectives of this experiment were twofold: to compare the effectiveness of a forehead-mounted reflectance oximeter and finger-mounted pulse oximeter for application in a hypoxia early warning detection system, and to determine whether the forehead-mounted sensor could be placed within an aviation helmet. METHODS: Subjects donned an aviation flight mask and were instrumented with a forehead reflectance oximeter, a finger pulse oximeter, a blood pressure cuff, and a skin temperature sensor. Following instrumentation, subjects breathed ambient air for 10 min through the Reduced Oxygen Breathing Device (ROBD) to allow for acclimation. The baseline period was followed by one of two counterbalanced ascent profiles used to model rapid exposures to altitude. Data were collected at 1 Hz from both sensors for the duration of the protocol. RESULTS: Analyses indicated an exceptionally strong agreement between the forehead and finger sensors at all ranges of desaturation. The sensitivity data revealed that the forehead sensor was significantly faster when responding to rapid changes in SpO2 than the finger. The sensor was successfully integrated inside the helmet; however, once donned by the subject, there was considerable artifact due to pressure fluctuations. DISCUSSION: While these data may seem to suggest that the forehead sensor is accurate and sensitive to altitude induced changes in SpO2, major drawbacks exist for the technology utilized in the current study. Significant improvements aimed at diminishing noise, curbing motion artifact, and improving reliability are required to reduce errant measurements.

A single dose of armodafinil significantly promotes vigilance 11 hours post-dose.

OBJECTIVE: This study was conducted to test the ability of armodafinil to promote vigilance among air traffic control operators 8 to 11 hours post-dose. METHODS: Forty-eight U.S. Naval air traffic control students were assigned to one of two groups, 150 mg dose of armodafinil or placebo. At 8:00 a.m., participants were administered armodafinil or a placebo, after which they completed a standard work day. Participants returned at 3:45 p.m. to complete the 4-hour performance portion of the study, where they performed the psychomotor vigilance task. RESULTS: The analysis showed a significant difference in vigilance between the armodafinil group and placebo (p < 0.05). Psychomotor vigilance task data revealed that participants receiving a 150 mg dose of armodafinil experienced significantly fewer lapses of attention compared to the control group. CONCLUSIONS: These results justify additional investigation into the efficacy of armodafinil to promote sustained vigilance in military operational settings where fatigue-related performance decrements are especially problematic.

The efficacy of low-dose intranasal scopolamine for motion sickness.

INTRODUCTION: Scopolamine is an effective motion sickness prophylactic, but oral and transdermal formulations are slowly absorbed. To enhance absorption and potentially efficacy, an intranasal formulation of scopolamine (INSCOP) was tested. METHOD: There were 16 motion sickness susceptible subjects with an average age of 23.5 +/- 3.0 yr and an average score of 11.3 +/- 4.7 on the Modified Motion Sickness Susceptibility Questionnaire-Short Form who volunteered to participate in the study. Each subject was given 0.4 mg of INSCOP and a placebo in a randomized, double-blind crossover design and, at 40 min post-dose, experienced Coriolis cross-coupling in a staircase progression until moderate nausea. Efficacy data and cognitive, physiological, and alertness assessments were collected during baseline control and throughout experimental testing. RESULTS: Intranasal scopolamine significantly increased the mean number of head movements tolerated [INSCOP 275.9 +/- 120.5, Placebo 230.7 +/- 76.4; t (15) = 2.21]. Estimation of medication absorption via plasma concentration indicated the drug was absorbed relatively rapidly to measurable levels by 15 min post-administration. Diastolic blood pressures and heart rate were significantly lower after administration of INSCOP compared to placebo. No significant cognitive or medication side effects were reported. Subjects reported no significant decrease in alertness as indicated by the Karolinska Sleepiness Scale. CONCLUSIONS: Results of the current study strongly suggest that intranasal scopolamine is efficacious for the treatment of motion sickness in susceptible individuals with no significant cognitive or sedative effects. Intranasal delivery offers a promising alternative for use in dynamic operational environments without cognitive detriment or increased side effects.