💬In plain words
What the trial is, and whether it could suit you
The investigators propose to expand our previous work to test whether 10 repeated administrations of the cTBS procedure over a two-week period can lead to longer-term improvements in sleep, perhaps up to 3-months. For this 3-year study, 120 people with insomnia will be recruited to participate. There will be an initial screening, with the first consent form being for the screening questions, a psychological interview, and a one night at home sleep monitoring session with our equipment. If participants pass this first phase, they will reconsent for the main portion of the study. They will then undergo a physical examination, then a week-long at-home monitoring phase where they will wear a wristwatch sleep monitor as well as wear a portable brain wave monitor to bed each night to record sleep. Participants will continue to use this equipment throughout the treatment phase and for one week
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Healthy men and non-pregnant women 18-60 (inclusive) years of age free from contraindicated diseases, medications, devices, and conditions.
* Must score in the moderate or higher range on the Insomnia Severity Index (ISI ≥ 15)
* Must meet the criteria for DSM-5 insomnia disorder as determined by a clinical interview with a board-certified sleep medicine physician.
* Sex ratio will be set to \~50% males; \~50% females
* Ethnicity ratio will be set to \~29.5% who identify as a minority; \~70.5% who identify as white
Exclusion Criteria:
* Presence of any metal implant or medical device that may pose a safety risk for MRI or TMS (permanent hearing aids, cochlear implants, medication infusion devices, brain stimulation devices, permanent retainer, etc.)
* Self-reported past or present medical diagnosis of sleep or breathing-related disorders such as sleep apnea other than insomnia (potential confounder);
* Confounder of Obstructive Sleep Apnea as measured by WatchPAT device at home
* Travel outside the time zone within the one week prior to the physical visit and at any point while active in the study (known to affect sleep);
* Regular shiftwork within 6-months prior to enrollment in the study (known to affect sleep);
* Self-reported past or present history of any seizures or seizure disorders or other contraindication to neurostimulation, for self or any first-degree relatives (safety concern);
* Self-reported current use of certain prescription medications that can either influence seizure threshold, or neuroimaging findings (safety concern and potential confounder);
* 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 (known to affect sleep; potential confounder);
* Self-reported or suspected substance abuse or dependence (safety concern; potential confounder);
* (Females only) Positive urine pregnancy result (Urine HCG Test results) (safety concern);
* Inability to read and sign the consent form (regulatory/ethical issue)
* Self-reported history of repeated, recent, or severe fainting spell or syncope
* Prior spinal cord surgeries or any spinal/ventricular derivations
* Self-reported negative experience due to neurostimulation before
* Deviation from self-reported normal bedtime sleep schedules (bedtime between 9:00 pm and 1:00 am
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