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RECRUITING
NCT07830056
PHASE4

Modafinil to Optimize the Performance of Cold-Stressed Sleep-Deprived Personnel

Sponsor: United States Army Research Institute of Environmental Medicine

View on ClinicalTrials.gov

Summary

Environmental and workplace stressors are common and often unavoidable in military operations. Two critical stressors are cold stress and sleep loss. They both can substantially degrade operational effectiveness. Various countermeasures are available to mitigate the adverse effects of these stressors, but due to operational requirements many are of limited use in the field. Modafinil is a drug that mitigates the effects of sleep deprivation and potentially cold stress, and modafinil may prevent performance degradation due to the combination of these stressors. This study will help determine if modafinil alters body-heat production and prevents cognitive and physical performance degradation due to cold stress in rested and sleep-deprived volunteers.

Key Details

Gender

All

Age Range

17 Years - 39 Years

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2025-02-18

Completion Date

2026-12

Last Updated

2026-09-21

Healthy Volunteers

Yes

Interventions

DRUG

Modafinil (M)

Evaluating the effect of Modafinil under both sleep deprivation and acute cold exposure on thermoregulation, cognitive flexibility/performance, and dexterity.

DRUG

200 mg Microcrystalline Cellulose

Placebo intervention to compare to modafinil intervention.

Locations (1)

US Army Research Institute of Environmental Medicine

Natick, Massachusetts, United States