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

Part of paid clinical trials in Natick, Massachusetts.

Sponsor
United States Army Research Institute of Environmental Medicine
Study ID
NCT07830056
Phase
PHASE4
Status
Recruiting
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Conditions

  • Cold Exposure
  • Sleep Deprivation

Eligibility Criteria

Sex
ALL
Age
17 Years - 39 Years
Healthy Volunteers
Accepted

Interventions

  • Modafinil (M) — DRUG
    Evaluating the effect of Modafinil under both sleep deprivation and acute cold exposure on thermoregulation, cognitive flexibility/performance, and dexterity.
  • 200 mg Microcrystalline Cellulose — DRUG
    Placebo intervention to compare to modafinil intervention.

Study Details

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 Dates

First listed
Sep 21, 2026
Start date
Feb 18, 2025
Status verified
Sep 2026
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
33 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    200 mg Microcrystalline Cellulose
  • Active Comparator: Modafinil
    200 mg Modafinil

Primary Outcome Measure

Height (in) [ Time Frame: Familiarization 1 (Day -2) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
US Army Research Institute of Environmental MedicineNatickMassachusetts01760
Harris R Lieberman, PhD
[email protected]
508-206-2326
Danielle M Arcidiacono, MS
[email protected]
508-206-2404
Harris R Lieberman, PhD (PRINCIPAL_INVESTIGATOR)

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