Using Transcranial Magnetic Stimulation to Improve Sleep Quality

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

This study is testing if a new treatment using magnetic stimulation can help people with insomnia sleep better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: University of Arizona (Academic / other)
• Locations: 1 site (Tucson, Arizona)
• Trial ID: NCT06631209 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of transcranial magnetic stimulation (TMS) applied to the default mode network to enhance sleep quality in individuals suffering from insomnia. Over a three-year period, 120 participants will undergo a series of screenings and assessments, including psychological interviews and sleep monitoring, to determine their eligibility. Those who qualify will receive 10 sessions of TMS treatment over two weeks, with ongoing monitoring of their sleep patterns for up to three months post-treatment. The study aims to evaluate both immediate and long-term improvements in sleep quality.

Who should consider this trial

Good fit: Ideal candidates are healthy men and women aged 18-60 who meet the criteria for insomnia disorder and score moderately or higher on the Insomnia Severity Index.

Not a fit: Patients with metal implants or other sleep disorders, such as obstructive sleep apnea, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve sleep quality for patients suffering from insomnia.

How similar studies have performed: Previous studies have shown promise in using TMS for various neurological conditions, suggesting potential for success in this novel application for insomnia.

Eligibility criteria

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

Where this trial is running

Tucson, Arizona

• SCAN Lab — Tucson, Arizona, United States (Recruiting)

Study contacts

• Study coordinator: William Killgore, Ph.D.

Conditions Insomnia; Sleep Quality; Transcranial Magnetic Stimulation