Is NCT07830056 recruiting in Natick, MA?

Yes, NCT07830056 is currently enrolling participants at its Natick, MA location. This sleep deprivation clinical trial is accepting qualified participants.

How do I join the sleep deprivation clinical trial in Natick?

To join this clinical trial in Natick, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Natick clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Sleep Deprivation Clinical Trial in Natick, MA: Modafinil (M) (Phase 4)

About This Sleep Deprivation Study in Natick

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.

Sponsor: United States Army Research Institute of Environmental Medicine

Who Can Participate

Inclusion Criteria

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).

Willing to consume study diets throughout the course of the study.

Supervisory approval for participation if permanent party military or a federal employee.

Exclusion Criteria

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. c. Individuals taking substances which induce CYP3A4 (carbamazepine, phenobarbital, rifampin) to a greater than minimal degree: systemic steroids; anti-gout agents (Exceptions can be recommended to PI for CYP3A4 inducers which do not fall into other listed categories). d. Individuals taking substances which are metabolized by CYP450 enzymes 1A2, 2B6, 2C19, or 3A4: immune-suppressant/-modulatory drugs; SSRIs; TCAs; anti-coagulants; antituberculosis agents; antimalarials; antineoplastic agents; antibody-derived drugs; antivirals; azole antifungals; anti-parasitic agents; abortive migraine medications; muscle relaxants; sex hormones or modulators; ibrexafungerp; lefamulin; palovarotene; propranolol.

Females who are pregnant or breastfeeding, have a positive- pregnancy test, or plan on becoming pregnant in the next 3 months.

Individuals currently taking/using contraceptives (i.e., oral contraceptive pill, intrauterine device, contraceptive implant, contraceptive injection, etc.) other than condoms.

Current or history of mental health issues, illness, or condition (i.e., attention deficit hyperactivity disorder, autism spectrum disorder, diagnosed depression or anxiety disorders) that OMSO physician/healthcare provider believes puts the volunteers at increased risk.

Current or history of psychosis, or history of suicidal or homicidal ideations within the past 2 years.

History of cold injuries or cold-induced asthma.

Raynaud's syndrome.

Previous hand/finger injuries that impair dexterity and hand function.

Metal hardware (plates/screws) in the upper extremities (arm/hands).

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).

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).

Diagnosed sleep disorders (i.e., sleep-apnea, narcolepsy, etc.).

Diseases and disorders of the metabolic, cardiovascular, endocrine, neurological, or gastrointestinal systems that in determination of OMSO are expected to interfere with safe conduct of the study.

A medical diagnosis of high blood pressure (hypertension).

Heart problems or prior heart attack.

Regular daily use of medication that may significantly interfere with the study drug or outcomes, as determined by the OMSO physician/healthcare provider.

Known allergies to medical adhesives.

Difficulty swallowing large pills (self-reported) for those individuals unwilling to utilize the rectal suppository of the telemetric pill.

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.

Donated blood within 8 weeks prior to study participation.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Natick?

Yes, this clinical trial (NCT07830056) has an active research site in Natick, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Sleep Deprivation Treatment Options in Natick, MA

If you're searching for sleep deprivation treatment options in Natick, MA, this clinical trial (NCT07830056) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Natick research site is actively enrolling participants for this phase 4 clinical trial. You'll receive care from experienced sleep deprivation specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all sleep deprivation clinical trials near you to find additional studies recruiting in your area.

Sleep Deprivation Clinical Trial in Natick, MA

Expert Care in Natick

IRB Approved

No-Cost Care

Apply for This Natick Location

Why Participate?

Simple Process