Tucson, AZNCT04953559Now EnrollingIRB Ready

Insomnia, Primary Clinical Trial in Tucson, AZ

Access cutting-edge insomnia, primary treatment through this clinical trial at a research site in Tucson. Study-provided care at no cost to qualified participants.

Sponsored by University of Arizona

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Expert Care in Tucson

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related insomnia, primary treatment provided free

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Check if you qualify for this insomnia, primary clinical trial in Tucson, AZ

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Why Participate?

  • No-Cost Study Care

  • Local to Tucson

    Convenient for AZ residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Tucson site if eligible
  4. 4Begin participation

About This Insomnia, Primary Study in Tucson

Insomnia is generally believed to be caused by excessive arousal of the brain and body. Rather than transitioning normally and quickly from wakefulness to sleep, individuals with insomnia tend to enter into a self-perpetuating cycle of self-referential thought and arousal. Brain imaging research has shown that these same internally focused self-reflective thoughts tend to activate a core system in the brain known as the Default Mode Network (DMN). The DMN is usually active when a person is internally focused, such as during daydreaming or mind wandering, but tends to be deactivated when the brain is focused on the external environment. The investigators hypothesize that excess activation and connectivity of this brain network may perpetuate internal conversations, worry, and rumination, preventing individuals with insomnia from falling asleep quickly and remaining asleep. Therefore, the goal of the present study is to use a brain stimulation technique known as transcranial magnetic stimulation (TMS) to target the DMN and slightly reduce its activation before bed. This should result in an easier time falling asleep. For this study, the investigators will recruit 20 healthy individuals and have them sleep in the lab on two occasions. On one occasion, they will be stimulated with a type of TMS called continuous theta burst stimulation (cTBS), which will be targeted toward their DMN. They will then try to sleep in the lab while the investigators record their brain waves using a technique known as polysomnography (PSG). On the other occasion, these same individuals will undergo the same procedure, but the TMS machine will be in a deactivated mode to present a "sham" stimulation. Participants will again try to sleep in the lab following the sham treatment while being recorded with PSG. Neither the participants nor the experimenters will know which condition the participant is receiving at the time. This will only be revealed later. Additionally, all participants will receive a brain scan just before and just after the TMS procedures so that the investigators can examine changes in brain connectivity and chemistry. The investigators expect that the participants will sleep better following the cTBS than following the sham condition and that this will be associated with measurable differences in their brain connectivity and brain chemistry. If effective, this project would have identified an innovative and novel approach for improving sleep without using drugs.

Sponsor: University of Arizona

Who Can Participate

Inclusion Criteria

Healthy men and non-pregnant, non-lactating women 18-50 (inclusive) years of age, free from contraindicated diseases, medications, devices, and conditions.
Participants must meet the criteria for primary insomnia as determined by scores on the ISI, PSQI, and ESS. Participants must obtain two out of three of the following required scores for each questionnaire:
Greater than or equal to 15 for ISI (Gagnon, Belanger, Ivers, \& Morin, 2013)
Greater than or equal to 6 for PSQI (Buysse et al 1989)
Greater than or equal to 11 for ESS (Johns, 2000)

Exclusion Criteria

Presence of any metal implant or medical device which may pose a safety risk for MRI or TMS (see below for examples)
Cardiac pacemakers
Metal clips on blood vessels (also called stents)
Artificial heart valves
Artificial arms, hands, legs, etc.
Brain stimulator devices
Implanted drug pumps
Ear implants
Eye implants or known metal fragments in eyes
Exposure to shrapnel or metal filings (wounded in military combat, sheet metal workers, welders, and others)
Other metallic surgical hardware in vital areas
Certain tattoos with metallic ink
Certain transdermal (skin) patches such as NicoDerm (nicotine for tobacco dependence), Transderm Scop (scopolamine for motion sickness), or Ortho Evra (birth control)
Past or present history of sleep or breathing-related disorders such as sleep apnea (exclusion upon obtaining a score of 3 or higher on the STOP-BANG questionnaire)
Travel outside the time zone within the two weeks prior to enrollment visit and at any point while active in the study
Self-reported major medical problems including past or present history of heart problems and/or neurological problems (to include but not limited to heart murmur, heart attack, TBI, stroke, tumor, epilepsy or another seizure disorder)
Self-reported past or present history of cardiovascular disease (to include but not limited to arrhythmias, valvular heart disease, congestive heart failure, history of sudden cardiac death or myocardial infarction)
Self-reported past or present history of neurological disorder (to include but not limited to traumatic brain injury including concussions, strokes, tumors, epilepsy or another seizure disorder, amnesia for any reason, hydrocephalus, multiple sclerosis)
Self-reported past or present history of any seizures or seizure disorders
Self-reported first-degree family history (like a mother, father, or sibling) of a seizure or seizure disorder
Self-reported underlying acute or chronic pulmonary disease requiring daily inhaler use
Self-reported history of fainting spells or syncope
Self-reported past (at any point in the participant's history) or present psychiatric problems not including depression and/or anxiety disorders (to include but not limited to bipolar, mania, ADHD, or psychotic disorders)
Self-reported history of depression and/or anxiety disorders within the past 2 years
Self-reported suicidal ideation as indicated by a score equal to or greater than 2 on the BDI
Self-reported current use of certain prescription medications including Ambien, benzodiazepines, stimulants (amphetamines, medication for narcolepsy), antidepressants (SSRIs, SNRIs), antipsychotics, blood pressure medications, thyroid medications.
Self-reported current use of supplements that may affect sleep (to include but not limited to melatonin, valerian root, kava root)
Self-reported caffeine use in excess of 300 mg (e.g., approximately 8 caffeinated sodas or approximately 3-4 12-oz cups of coffee) per day on average
Self-reported or suspected regular nicotine use (or addiction) (defined as more than 1 cigarette or equivalent per week within the last 1 year)
Self-reported or suspected heavy alcohol use (minimum limit to define heavy alcohol use is 14 drinks per week)
Self-reported or suspected use of illicit drugs (to include but not limited to benzodiazepines, amphetamines, cocaine, opioids)
(Females only) Positive urine pregnancy result (Urine HCG Test results)
(Females only) Self-reported or suspected current breast-feeding or collecting breast-milk
Learned English past age 3
Speaking English as a non-primary language
Less than 9th grade education
Unusual sleep schedules in past six months
Overnight shift work
Inability to read and sign consent
Failure to cooperate with requirements of the study

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 Tucson?

Yes, this clinical trial (NCT04953559) has an active research site in Tucson, AZ 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.

Insomnia, Primary Treatment Options in Tucson, AZ

If you're searching for insomnia, primary treatment options in Tucson, AZ, this clinical trial (NCT04953559) 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 Tucson research site is actively enrolling participants for this clinical trial. You'll receive care from experienced insomnia, primary 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 insomnia, primary clinical trials near you to find additional studies recruiting in your area.

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