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New treatment option for Insomnia, Primary
Official title Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep
ClinicalTrials.gov ID: NCT04953559
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50
You may be able to join if
- Healthy men and non-pregnant, non-lactating women 18-50 (inclusive) years of age, free from contraindicated diseases, medications, devices, and...
- 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...
- 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)
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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)
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.