Zapping the brain to beat insomnia: new study tests TMS for better sleep
NCT ID NCT06631209
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a non-invasive brain stimulation technique called TMS can improve sleep in people with insomnia. 144 adults with moderate to severe insomnia will receive either real TMS to different brain areas or a sham (inactive) treatment over two weeks. Researchers will track sleep changes using home monitors and brain scans to see if the effects last up to three months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 144 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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SCAN Lab
RECRUITINGTucson, Arizona, 85724, United States
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Other studies related to the condition(s) this trial covers.
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