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Transcranial Magnetic Stimulation for Insomnia

This study is looking at whether a treatment called Transcranial Magnetic Stimulation (TMS) can help improve sleep for people with insomnia. Specifically, it uses a type of TMS called Continual Theta Burst Stimulation. Researchers want to see if 10 treatments over two weeks can lead to better sleep for up to three months. You might be able to join if you are 18-60 years old, have moderate to severe insomnia, and meet other health criteria. The study will measure changes in your sleep stages, how much you worry about sleep (Pre-Sleep Arousal Scale), and your overall insomnia severity (Insomnia Severity Index) to see if the treatment is successful. The study is currently recruiting 144 participants, but its status is unclear.

Study design
This interventional study plans to enroll 144 participants. It compares active Transcranial Magnetic Stimulation (TMS) to a sham (inactive) TMS treatment.
What's involved
You will go through an initial screening with questionnaires, a psychological interview, and one night of at-home sleep monitoring. If eligible, you will then undergo 10 TMS treatments over two weeks.
Compensation
Not stated in the trial record.
Follow-up
Your sleep will be monitored for changes at 1 month, and your insomnia severity and pre-sleep arousal will be measured at 4 months after the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06631209

Effectiveness of Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep - Clinical Trial

Recruiting
NAAges 18–60InterventionalTreatment
University of Arizona
~144 participants
Updated 2025-11-04 on ClinicalTrials.gov
What's tested:Transcranial Magnetic Stimulation (TMS)Sham

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sleep stage changes as determined by Polysomnography
Measured over 1 month
+7 more outcomes measured

Conditions

Insomnia

Explore related trials

Insomnia

Where it's being run

1 sites across 1 states
Arizona1

Who to contact

William Killgore, Ph.D.
[email protected]
520-621-0605
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Sleep stage changes as determined by Polysomnography1 month

    PSG will be taken nightly during at home monitoring and treatment

  • Change in scores on the Pre-Sleep Arousal Scale (PSAS)4 months

    Scale will be taken daily for main 4 weeks of study and taken again at 1 month and 3 month followup. Total score ranging from 16-80. Two subscores (somatic and cognitive arousal) ranging from 8-40. Higher scores indicating greater arousal

  • Change in Insomnia Severity Index (ISI) score4 months

    Scale will be taken before and after treatment and at followups at 1 month and 3 months. Score ranging from 0-28 with higher scores indicating greater levels of insomnia.

  • Sleep duration change as determined by Polysomnography1 month

    PSG will be taken nightly during at home monitoring and treatment

  • Sleep efficiency change as determined by Polysomnography1 month

    PSG will be taken nightly during at home monitoring and treatment

  • Sleep latency change as determined by Polysomnography1 month

    PSG will be taken nightly during at home monitoring and treatment

  • Wakefulness after sleep onset (WASO) change as determined by Polysomnography1 month

    PSG will be taken nightly during at home monitoring and treatment

  • Change in DMN within-network connectivity during resting state3 weeks

    fMRI data will be collected during resting state in the scanner for pre and post