Effects of Accelerated rTMS on Sleep Architecture in Chronic Insomnia Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorSan Francisco Neurology and Sleep Center
About this trial
Chronic insomnia disorder is a common condition in which people have ongoing difficulty falling asleep, staying asleep, or waking too early. It affects about 10-12% of adults and can lead to daytime problems, stress, and other health issues. Current treatments include talk therapy (cognitive behavioral therapy for insomnia) and sleep medications, but medications can have side effects and may not work well over the long term.
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive treatment that uses magnetic pulses applied to the scalp to stimulate specific areas of the brain. It has shown promise in improving sleep quality in people with insomnia by targeting a brain region called the left dorsolateral prefrontal cortex, which plays a role in the overactive brain arousal thought to cause insomnia.
The purpose of this study is to find out whether an accelerated course of rTMS using the EXOMIND™ device can improve sleep in adults with chronic insomnia disorder. The study will enroll approximately 70 participants aged 18 to 85 years at a single site in San Francisco. Participants will receive 6 rTMS sessions (3 times per week for 2 weeks). Each session lasts about 25 minutes.
The study has three phases: a screening phase (up to 25 days) to confirm eligibility using sleep questionnaires and at-home sleep monitoring, a 2-week open-label treatment phase, and a follow-up phase with visits at 1 month and 3 months after the last treatment session. Total participation lasts up to approximately 139 days.
The main goal is to measure whether insomnia severity improves after treatment, using a standard questionnaire called the Insomnia Severity Index (ISI). The study will also measure changes in objective sleep patterns (such as how long it takes to fall asleep, time spent in deep sleep, and total sleep time) recorded by a home sleep monitoring device, as well as changes in sleep quality, stress levels, and overall clinical impression of improvement.
This is an open-label pilot study, meaning all participants will receive the rTMS treatment and there is no placebo group. The study does not involve any medications. Participants must not have certain medical conditions, electronic or metal implants in or near the head, untreated sleep apnea, or active serious psychiatric disorders. Participants who are pregnant or breastfeeding cannot take part.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject must be 18 to 85 years of age, inclusive, on the day of signing informed consent.
Subject must meet DSM-5 criteria for insomnia disorder：
Subject must have an ISI total score ≥15 at screening.
Subject must have an sSOL ≥45 minutes and an sWASO ≥60 minutes on at least 3 nights over any 7-day period during Part 1 of screening, using the CSD-M, prior to screening Somfit™ sleep test assessments.
Disqualifiers
Has history of or current clinically significant and/or unstable liver (moderate or severe hepatic impairment [Child-Pugh Score ≥7]) or renal insufficiency (severe renal impairment [estimated creatinine clearance below 30 mL/min]; serum creatinine >2 mg/dL); significant and/or unstable cardiac, vascular, pulmonary (eg, acute or severe respiratory failure), gastrointestinal, endocrine, neurologic (eg, myasthenia gravis, narcolepsy), hematologic, rheumatologic, immunologic, or metabolic disturbances. Organic brain disease, epilepsy, dementia, narcolepsy, narrow angle glaucoma and known or suspected mental retardation are exclusionary. Any clinically relevant medical condition that is likely to result in deterioration of the subject's condition or affect the subject's safety during the study (eg, medically frail subject with history of hospitalization due to fractures) or could potentially alter the absorption, metabolism, or excretion of the study drug is exclusionary.
Has uncontrolled hypertension (supine systolic blood pressure >150 mm Hg in adult subjects or >160 mm Hg in elderly subjects or supine diastolic blood pressure >90 mm Hg, despite diet, exercise, or a stable dose of allowed antihypertensive therapy) at screening or Day 1. (A subject with hypertension may be included if the subject's hypertension has been controlled for at least 3 months prior to screening, and the dosage of any antihypertensive medication has been stable for the past 3 months).
Has clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening. Subjects with non-insulin dependent diabetes mellitus who are adequately controlled (hemoglobin A1c [HbA1c] ≤8%) may be eligible to participate if otherwise medically healthy. It is expected that laboratory values will generally be within the normal range, though minor deviations, which are not considered to be of clinical significance to both the investigator and the sponsor's Safety Physician, are acceptable.
Electronic implants in or near the head - rTMS devices are contraindicated for use in patients who have active or inactive implants in or near the head including device leads, deep brain stimulators, cochlear implants, ocular implants, and vagus nerve stimulators, implanted devices such as cardiac pacemakers, defibrillators, and neurostimulators.
Trial design
Design model
Single group
Treatments tested in this trial
TMS
DeviceThe EXOMIND™ (BTL-699-2) is a repetitive transcranial magnetic stimulation (rTMS) device that delivers targeted electromagnetic pulses to cortical brain regions. In this study, stimulation is applied to the left dorsolateral prefrontal cortex (DLPFC), a region implicated in executive function, working memory, and attention. The DLPFC target is localized using the standard 5-cm rule, measured anterior to the motor cortex hot spot. Each treatment session uses a multi-frequency protocol alternating between 12, 15, and 18 Hz stimulation frequencies, delivering a total of 6,300 pulses over 24 minutes and 30 seconds. Stimulation intensity is calibrated to each participant's resting motor threshold, defined as the minimum stimulus intensity required to produce a visible contraction of the right abductor pollicis brevis muscle. Six sessions are administered twice weekly over approximately 3 weeks.
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: rTMS TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change From Baseline in Insomnia Severity Index (ISI) Total Score at 1-Month Follow-Up
The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire that assesses the nature, severity, and impact of insomnia. Each item is rated on a 0-4 Likert scale, yielding a total score ranging from 0 to 28. Higher scores indicate greater insomnia severity. Clinical severity categories are: 0-7 (no clinically significant insomnia), 8-14 (subthreshold insomnia), 15-21 (moderate clinical insomnia), and 22-28 (severe clinical insomnia). The primary outcome is the change in ISI total score from baseline (Day 1, pre-treatment) to the 1-month follow-up visit. A negative change indicates improvement.
Time frame
From baseline to the 1-month follow-upSecondary outcomes
1
Change From Baseline in Sleep Onset Latency (SOL)
Sleep onset latency (SOL) is defined as the time in minutes from lights off to the first epoch of any sleep stage, as measured by the Somfit™ home EEG recording device. A negative change from baseline indicates faster sleep onset and improvement.
Time frame
Baseline (night before Day 1), day of last rTMS session (approximately Day 21), 1-month follow-up (approximately Day 51), and 3-month follow-up (approximately Day 111)2
Change From Baseline in Stage N3 Duration
Stage N3 duration is defined as the total time in minutes spent in N3 (deep/slow-wave) sleep during the recording period, as measured by the Somfit™ home EEG recording device. N3 sleep is the deepest stage of non-REM sleep and is associated with restorative functions. A positive change from baseline indicates an increase in deep sleep and improvement.
Time frame
Baseline (night before Day 1), day of last rTMS session (approximately Day 21), 1-month follow-up (approximately Day 51), and 3-month follow-up (approximately Day 111)3
Change From Baseline in Wake After Sleep Onset (WASO)
Wake after sleep onset (WASO) is defined as the total time in minutes spent awake after initial sleep onset until the final awakening, as measured by the Somfit™ home EEG recording device. A negative change from baseline indicates less nighttime wakefulness and improvement.
Time frame
Baseline (night before Day 1), day of last rTMS session (approximately Day 21), 1-month follow-up (approximately Day 51), and 3-month follow-up (approximately Day 111)4
Change From Baseline in Total Sleep Time (TST)
Total sleep time (TST) is defined as the total time in minutes spent in any sleep stage (N1, N2, N3, and REM) during the recording period, as measured by the Somfit™ home EEG recording device. A positive change from baseline indicates more sleep and improvement.
Time frame
Baseline (night before Day 1), day of last rTMS session (approximately Day 21), 1-month follow-up (approximately Day 51), and 3-month follow-up (approximately Day 111)Sponsors and contacts
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Source ClinicalTrials.gov
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