Prevention of cognitive and physical performance decline associated with multi-stressor conditions (i.e., sleep-deprivation, cold exposure) Not Applicable
Conditions
Interventions
Administration of 200 mg of modafinil every 12 hours during a continuous 33-hour data collection period in an environmental chamber to simulate cold weather operations.
Sixteen volunteers will be tes
Sponsors
United States Army Medical Research and Development Command
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Active-duty U.S. Army Soldiers 18-39 years old 2. Willing to refrain from the use of caffeine – including dietary supplements that contain caffeine – alcohol, and nicotine 24 hours prior to data collection 3. Willing to refrain from vigorous physical activity 24 hours prior to data collection 4. Willing to 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 5. Willing to consume study diets throughout the course of the study 6. Supervisory approval for participation
Exclusion criteria
Exclusion criteria: 1. Use of modafinil or armodafinil in the last 3 months 2. Known allergy to modafinil or armodafinil 3. Current medical profile, or condition (i.e., musculoskeletal injury), that limits or compromises physical activity/exercise capability 4. Individuals taking medication known to interact with modafinil such as methylphenidate, dextroamphetamine, clomipramine, MAO inhibitors, ethinyl estradiol, phenytoin, cyclosporine (or other drugs that depend on CYP1A2, CYP2B6, and CYP3A4 for their clearance), tricyclic antidepressants, selective serotonin reuptake inhibitors, inducers of CYP3A4 (e.g., carbamazepine, phenobarbital, rifampin) or inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole), 5. Females who are pregnant or breastfeeding, have a positive- pregnancy test, or plan on becoming pregnant in the next 3 months 6. Individuals currently taking/using contraceptives (i.e., oral contraceptive pill, intrauterine device, contraceptive implant, contraceptive injection, etc.) other than condoms. 7. Current or history of mental health issues, illness, or condition (i.e., attention deficit hyperactivity disorder, autism spectrum disorder, diagnosed depression or anxiety disorders). 8. Current or history of psychosis 9. History of cold injuries or cold-induced asthma 10. Raynaud’s syndrome 11. Previous hand/finger injuries that impair dexterity and hand function 12. Metal hardware (plates/screws) in the upper extremities (arms/hands) 13. Abnormal blood count (For example: hemoglobin (Hb) outside of the typical normal values reported by LabCorp in accordance with OMSO (Normal [Hb] Males = 12.6-17.7 g/dL; Females = 11.1-15.9 g/dL) or hematocrit (Hct) outside of the normal ranges (Normal Hct Males = 37.5-51.0%; Females = 34.0-46.6%) levels, presence of abnormal blood laboratory measures (e.g., hemoglobin S or sickle cell traits) 14. Current or history of alcohol abuse (defined as Harmful Use by the World Health Organization), those who meet criteria for alcohol abuse disorder (as outlined in the DSM-5), or other substance abuse (i.e., the use of illegal drugs or the use of prescription or over-the-counter drugs for purposes other than those for which they are meant to be used, or in excessive amounts).” 15. Diagnosed sleep disorders (i.e., sleep-apnea, narcolepsy, etc) 16. Diagnosed medical condition, such as diseases and disorders impacting metabolic, cardiovascular, neurological, gastrointestinal, or muscular systems 17. A medical diagnosis of high blood pressure (hypertension) 18. Heart problems or prior heart attack 19. Regular daily use of medication that may significantly interfere with the study drug or outcomes, as determined by physician/healthcare provider. 20. Known allergies to medical adhesives 21. Difficulty swallowing large pills (self-reported) for those individuals unwilling to utilize the rectal suppository of the telemetric pill. 22. History of obstructive disease of the gastrointestinal tract including (but not limited to) diverticulosis, diverticulitis and inflammatory bowel disease, peptic ulcer disease, Crohn’s disease, ulcerative colitis, or previous gastrointestinal surgery, etc. that OMSO physician/healthcare provider believes puts the volunteers at increased risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Body composition will be measured using dual x-ray absorptiometry (DXA) as well as via stadiometer (height) and calibrated electronic scale (weight) at baseline. 2. Cognitive performance and mood will be measured using the following cognitive tests during baseline and every 4 hours during the in-laboratory 2-day testing cycles: Scanning Visual Vigilance, Psychomotor Vigilance Task, Match-to-Sample, Grammatical Reasoning, N-back, Balloon Analogue Risk Task, Profile of Mood States, Buss-Perry Aggression Scale 3. Physical performance will be measured using the following tests during baseline and every 4 hours during in-laboratory 2-day testing cycles: Critical Power, Vertical Jump, Finger Tapping Test 4. Core and skin temperature will be measured continuously throughout each cold exposure; core temperature will be measured using a telemetric thermometer capsule (e-Celsius® Performance Capsule, BodyCap, Saint-Clair, France, or similar); skin temperature will be measured using sensors (thermistor or thermocouple type) attached at the volunteer’s chest, triceps, hand, thigh, calf, and foot. 5. Physical activity and sleep duration will be recorded with a wrist actigraphy monitoring system (Actiwatch Spectrum Plus, Koninklijke Philips N.V., Amsterdam, NL or equivalent device). An actigraph will be placed on the volunteer’s wrist during the baseline period and will be worn continuously through each testing cycle and through the final washout period. | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
United States of America
Contacts
Public ContactHarris Lieberman
Outcome results
None listed