Phase
Condition
Insomnia
Treatment
Sham
Transcranial Magnetic Stimulation (TMS)
Clinical Study ID
Ages 18-60 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Healthy men and non-pregnant women 18-60 (inclusive) years of age free fromcontraindicated 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 clinicalinterview 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% whoidentify as white
Exclusion
Exclusion Criteria:
Presence of any metal implant or medical device that may pose a safety risk for MRIor 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-relateddisorders 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 atany point while active in the study (known to affect sleep);
Regular shiftwork within 6-months prior to enrollment in the study (known to affectsleep);
Self-reported past or present history of any seizures or seizure disorders or othercontraindication to neurostimulation, for self or any first-degree relatives (safetyconcern);
Self-reported current use of certain prescription medications that can eitherinfluence seizure threshold, or neuroimaging findings (safety concern and potentialconfounder);
Self-reported caffeine use in excess of 300 mg (e.g., approximately 8 caffeinatedsodas or approximately 3-4 12-oz cups of coffee) per day on average (known to affectsleep; potential confounder);
Self-reported or suspected substance abuse or dependence (safety concern; potentialconfounder);
(Females only) Positive urine pregnancy result (Urine HCG Test results) (safetyconcern);
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 pmand 1:00 am
Study Design
Study Description
Connect with a study center
SCAN Lab
Tucson, Arizona 85724
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.