Actively Recruiting
Effectiveness of Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep - Clinical Trial
Led by University of Arizona · Updated on 2025-11-04
144
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
Sponsors
U
University of Arizona
Lead Sponsor
U
U.S. Army Medical Research Acquisition Activity
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 post treatment. After the first monitoring phase, each participant will be randomly assigned to one of four different conditions (i.e., 30 assigned to each group). Three of the conditions will involve cTBS focused on different brain locations (i.e., stimulation to the middle front, middle back, or side of the skull), while the fourth condition will provide inactive sham stimulation as a control. All participants will complete 10 treatment visits to the lab over two-to-three weeks, during which they will get a brief cTBS or sham stimulation each time. In addition, all participants will complete a brain scanning and cognitive testing session at the beginning and end of the two-to-three week treatment period. Participants will also complete 1-month and 3-month online follow-up assessments to examine long-term effects.
CONDITIONS
Official Title
Effectiveness of Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep - Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy men and non-pregnant women aged 18 to 60 years
- Must have moderate or higher insomnia severity (Insomnia Severity Index score ≥ 15)
- Must meet DSM-5 criteria for insomnia disorder confirmed by clinical interview
- Sex ratio approximately 50% males and 50% females
- Ethnicity ratio approximately 29.5% minorities and 70.5% white participants
You will not qualify if you...
- Any metal implant or medical device posing MRI or TMS safety risk (e.g., hearing aids, cochlear implants, infusion devices, brain stimulation devices, permanent retainers)
- History or diagnosis of sleep or breathing disorders other than insomnia
- Obstructive Sleep Apnea as measured by home WatchPAT device
- Travel across time zones within one week before physical visit or during study
- Regular shift work within 6 months prior to enrollment
- History of seizures or seizure disorders or contraindications to neurostimulation in self or first-degree relatives
- Current use of medications affecting seizure threshold or neuroimaging results
- Caffeine consumption exceeding 300 mg per day on average
- History or suspicion of substance abuse or dependence
- Positive pregnancy test for females
- Inability to read and sign consent form
- History of repeated, recent, or severe fainting spells
- Prior spinal cord surgeries or spinal/ventricular derivations
- Negative prior experience with neurostimulation
- Regular bedtime outside 9:00 pm to 1:00 am range
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
SCAN Lab
Tucson, Arizona, United States, 85724
Actively Recruiting
Research Team
W
William Killgore, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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