Modafinil to Optimize the Performance of Cold-Stressed Sleep-Deprived Personnel
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age17-39
SponsorUnited States Army Research Institute of Environmental Medicine
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy, men and women aged 18-39 years old. Active-duty military personnel who are 17 years of age will also be allowed to participate.
Willing to refrain from the use of caffeine - including dietary supplements that contain caffeine - alcohol, and nicotine 24 hours prior to data collection.
Willing to refrain from vigorous physical activity 24 hours prior to data collection.
Willing to refrain from any dietary supplement use within one week of initial screening and at any time while enrolled in the study (except a multi-vitamin containing up to 100% RDA).
Disqualifiers
Use of modafinil or armodafinil in the last 3 months.
Known allergy to modafinil or armomodafinil.
Current medical profile, or condition, that limits, compromises, or is likely to render inconsistent performance with Grip Strength, Finger Tapping, or cardiovascular exercise on an exercise bike.
a. Individuals taking substances that directly interact with modafinil, alertness/attention/concentration, or sympathetic tone: stimulants; decongestants, barbiturates, bronchodilators; SNRIs; opioids; appetite suppressants; anti-obesity medications; b. Individuals taking substances which inhibit CYP3A4 (penicillins; macrolide antibiotics; fluoroquinolones; lomitapide; goldenseal) or MAO inhibitors.
Trial design
Design model
Crossover
Treatments tested in this trial
Modafinil (M)
DrugEvaluating the effect of Modafinil under both sleep deprivation and acute cold exposure on thermoregulation, cognitive flexibility/performance, and dexterity.
200 mg Microcrystalline Cellulose
DrugPlacebo intervention to compare to modafinil intervention.
Treatment groups
33 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: ModafinilActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Height (in)
Height will be measured in inches using a stadiometer.
Time frame
Familiarization 1 (Day -2)2
Body Weight (kg)
Body weight will be measured in kilograms using a calibrated electronic scale.
Time frame
Familiarization 1 (Day -2)3
Body Composition: DXA Fat Mass (lbs)
Fat mass will be measured in kilograms via dual x-ray absorptiometry and used to calculate body fat percentage (fat mass/body weight).
Time frame
Familiarization 1 (Day -2)4
Body Composition: DXA Lean Mass (lbs)
Lean mass will be measured in pounds using dual x-ray absorptiometry.
Time frame
Familiarization 1 (Day -2)Secondary outcomes
1
Cognitive Assessment: Balloon Analogue Risk Task (BART)
The BART is used to assess risk-taking behavior, reportedly altered by sleep loss. Volunteers will repeatedly fill simulated balloons with air, and points are awarded each time the balloon inflates with air without "popping it". The more the balloon is inflated, the more points are earned. Volunteers can bank their points at any time. All points accumulated that are not banked will be lost if the balloon pops. Simulated balloons will randomly pop after either 8, 32, or 128 puffs. Volunteers will be scored based on how many balloons are popped in each of these categories.
Time frame
Familiarization 1 (Day -2), Familiarization 2 (Day -1), Baseline Assessment (Day 0), Cold Exposure (Days 2 & 3), Cold Exposure (Days 6 & 7)2
Assessment of Blinding
Volunteers will complete a single item exit survey at the end of the second experimental visit to assess the potential of the placebo effect on cognitive and physical performance during cold exposures. Volunteers will be asked to report which experimental session they believe they consumed Modafinil, answering either: session 1, session 2, or not sure.
Time frame
Cold Exposure (Day 7)3
Dietary Intake
Volunteers will be prescribed a standardized diet (1.2 g/kg protein, 6 g/kg carbohydrate, 1 g/kg fat) to moderate the potential influence of diet on performance during the experimental visits. Diet prescription will be based on volunteer body mass measured at the first familiarization visit. Volunteers will start diet prescription 48 hours prior to the first experimental visit at baseline assessment, and continue study diet through completion of second experimental visit (8 days total). Study dieticians will prepare individual diets derived from military combat rations (MRE; Meal, Ready-to-Eat) and commercially available food items. Dietary intake will be verified by collecting wrappers/containers and any food or drink that is not entirely consumed will be weighed and accounted for.
Time frame
Baseline Assessment (Day 0) to Cold Exposure (Day 7)4
Cold Exposure: Environmental Symptoms Questionnaire (ESQ)
The ESQ was used to determine the effects of exposure to environmental extremes. A modified version of the ESQ was used to assess the effects relevant to cold exposure only. Volunteers were asked to rate statements on a scale from 1 (not at all) to 5 (extreme). Higher scores indicate that the volunteer is experiencing more severe symptoms of cold exposure.
Time frame
Familiarization 1 (Day -2), Familiarization 2 (Day -1), Baseline Assessment (Day 0), Cold Exposure (Days 2 & 3), Cold Exposure (Days 6 & 7)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
United States Army Research Institute of Environmental Medicine
Lead sponsor
U.S. Army Medical Research and Development Command
Collaborator
Source ClinicalTrials.gov