InsomniaNCT06631209
Effectiveness of Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep - Clinical Trial
A study testing Transcranial Magnetic Stimulation (TMS) in people with Insomnia, run by University of Arizona at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Transcranial Magnetic Stimulation (TMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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);
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
SCAN Lab
Tucson, Arizona, 85724
William Killgore, Ph.D., 520-621-0605, killgore@psychiatry.arizona.edu
About this study
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.
Read the detailed description
Phase 0: Screening and Rule-Outs:
During the REDCap Screening, participants will first read this informed consent form and sign it electronically on REDCap to proceed. To begin the screening questions, they must pass a 10-question comprehension check with questions regarding this document to ensure you understand the study. They will then answer a series of questionnaires related to demographics and health background. The REDCap screener will automatically end the survey if they indicate any exclusion. If you are included in the study, at the end of the screening questions it will indicate so and that we will be in contact with you shortly. They will then undergo a virtual psychological interview to determine if they indeed have Insomnia to qualify for the study. Then, they will be mailed WatchPAT monitoring equipment for them to utilize for one night of sleep monitoring at home. This device will measure their level of Obstructive Sleep Apnea, excluding them if they score \>15 AHI. We will review all of this data, and if they are eligible, participants will move on to Phase 1 of the study and undergo a second consent form.
Phase 1 In-Person Screening/Enrollment, Pre-Intervention:
Individuals who are eligible for this study after the three screening points will come into the lab to undergo an informational briefing and physical screening appointment. At this appointment, potential participants will complete the main consent for the rest of the study and get to ask any additional questions they have in person. Then, they will undergo a physical examination with a physician to determine eligibility. During the physical examination, there will be a collection of vital signs, EKG, and urine samples to screen for pregnancy and drugs (Ketamine, cocaine, MDMA, phenylcycline (PCP), and amphetamines). We will not be excluding for marijuana. In addition, individuals will complete evaluations to assess intelligence and cognition. If an individual is physically eligible and wishes to move forward, they will then be sent home and asked to complete 7 days of at-home sleep monitoring. This will include wearing an actigraph and a MUSE headband every night, while completing daily sleep diaries and short surveys every morning.
Phase-2 Baseline/Randomization/Active Intervention:
At the baseline visit participants will be asked to complete several cognitive and emotional assessments, have a pre-TMS neuroimaging scan and Electrocardiogram session, and undergo their first TMS administration. The first TMS administration will follow participant randomization into one of the four study conditions.
Following the baseline visit, during treatment participants will be asked to continue using the MUSE headband and actigraph every night and complete daily sleep diaries every morning. Participants will also be asked to return to the lab for 10 total TMS sessions in 2-3 weeks, all lasting around an hour in the evening. Participants will be administered a PVT task before and after each treatment session.
The kind of TMS we are administering is called Theta Burst Stimulation (TBS). A MagVenture MagPro X100 stimulator (MagVenture Inc. Denmark) connected with a figure-of-eight magnetic coil with active cooling will be used for the TBS protocol. Each individual is expected to have a different sensitivity to the magnetic fields generated by the cTBS, and the stimulation intensity will need to be adjusted based on each individual's resting motor threshold (RMT). Once we determine the RMT, we will set the machine to run at 70% of this level. The stimulation will last 40 seconds.
The ten TMS sessions will last for one hour between 6-9pm on weekdays. Ideally, there would be a session every weekday straight for two full weeks. We understand that this may be difficult for some people. If you need to miss a day or two, that is okay. However, 10 sessions are required. The maximum administration window is 3 weeks. The maximum number of days you can go between TMS sessions is 4 days. Please refrain from engaging in exercise in the time between your evening TMS session and when you go to bed.
Phase 3- Post-Intervention:
After participants complete the two-to-three-weeks of active intervention they will be asked to return to the lab to complete a post-intervention visit. This will involve the same testing as the pre-intervention (baseline) visit (MRI, surveys, and ECG). After this visit, participants will be sent home to continue recording sleep/activity for 7 more nights with the MUSE headband and actigraph, as well as continue recording sleep diaries and short surveys. This is the same as the at-home visit pre-intervention. After post-monitoring, participants will return to the lab for their final close-out visit. During this visit participants will return all study equipment and that will be the last of the in-person visits.
Phase 4- Follow-Up:
Participants who agree during the consent process will be contacted 1-month and 3-months after study completion to complete a series of brief assessments on REDCap, as well as another Psychological Interview at the 1-month follow-up.
- Conditions
- Insomnia
- Being tested
- Transcranial Magnetic Stimulation (TMS), Sham
- Keywords
- Sleep Quality, Transcranial Magnetic Stimulation
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS)Device
Specifically, Continual Theta Burst Stimulation
ShamOther
Sham TMS
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation - Posterior Cingulate Cortex | Active comparator | Active Stimulation targeted at the Posterior Cingulate Cortex Receives: Device: Transcranial Magnetic Stimulation (TMS) |
| Active Stimulation - Inferior Parietal Lobule | Active comparator | Active Stimulation targeted at the Inferior Parietal Lobule Receives: Device: Transcranial Magnetic Stimulation (TMS) |
| Active Stimulation - Dorsomedial Prefrontal Cortex | Active comparator | Active Stimulation targeted at the Dorsomedial Prefrontal Cortex Receives: Device: Transcranial Magnetic Stimulation (TMS) |
| Sham Stimulation | Sham comparator | The TMS device will be placed to the head but no energy will be emitted. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep stage changes as determined by Polysomnography
PSG will be taken nightly during at home monitoring and treatment
Measured: 1 month
Change in scores on the Pre-Sleep Arousal Scale (PSAS)
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
Measured: 4 months
Change in Insomnia Severity Index (ISI) score
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.
Measured: 4 months
Sleep duration change as determined by Polysomnography
PSG will be taken nightly during at home monitoring and treatment
Measured: 1 month
Sleep efficiency change as determined by Polysomnography
PSG will be taken nightly during at home monitoring and treatment
Measured: 1 month
Sleep latency change as determined by Polysomnography
PSG will be taken nightly during at home monitoring and treatment
Measured: 1 month
Wakefulness after sleep onset (WASO) change as determined by Polysomnography
PSG will be taken nightly during at home monitoring and treatment
Measured: 1 month
Change in DMN within-network connectivity during resting state
fMRI data will be collected during resting state in the scanner for pre and post
Measured: 3 weeks
Secondary outcomes (32)
Change in DMN activity during a cognitively demanding task
fMRI data will be collected during a task in the scanner for pre and post
Measured: 1 week
Change in GABA levels in the posterior cingulate cortex
Spectroscopy data will be collected during resting state in the scanner for pre and post
Measured: 3 weeks
Change in glutamate/glutamine (glx) levels in the posterior cingulate cortex
Spectroscopy data will be collected during resting state in the scanner for pre and post
Measured: 3 weeks
Correlation between changes in GABA/glx levels and changes in resting state functional connectivity within the DMN
Spectroscopy and fMRI data will be collected during resting state in the scanner for pre and post
Measured: 3 weeks
Correlation between changes in GABA/glx levels and changes in functional deactivation of the DMN during a cognitive challenge task
Spectroscopy and fMRI data will be collected in the scanner for pre and post
Measured: 3 weeks
Change in lactate levels in the posterior cingulate cortex
Spectroscopy data will be collected during resting state in the scanner for pre and post
Measured: 3 weeks
Change in dynamic diffusion along the perivascular space
Dynamic diffusion data will be collected during resting state in the scanner for pre and post
Measured: 3 weeks
Change in scores on the Penn State Worry Questionnaire (PSWQ).
Scale will be taken at pre and post treatment, and taken again at 1 month and 3 month followup. Score ranging from 16-80, with higher scores indicating higher levels of worry
Measured: 4 months
Change in scores on the Epsworth Sleepiness Scale (ESS)
Scale will be taken before and after treatment and at 1 month and 3 months follow-ups. Score ranging from 0-24 with higher scores indicating greater sleepiness.
Measured: 4 months
Change in scores on the Functional Outcomes of Sleep Questionnaire (FOSQ)
Scale will be taken before and after treatment and at followups at 1 month and 3 months. Score ranging from 5-20 with lower scores indicating greater life impairment due to sleep.
Measured: 4 months
Change in spectral density measure of the EEG beta1 and beta2 frequency bands with a focus on the frontal electrodes (Fp1, F7, F8)
EEG will be collected every night during at-home monitoring and treatment
Measured: 1 month
Change in sleep duration determined by actigraphy
Actigraphy will be collected nightly during sleep period
Measured: 1 month
Change in sleep efficiency determined by actigraphy
Actigraphy will be collected nightly during treatment and at-home monitoring periods
Measured: 1 month
Change in sleep latency determined by actigraphy
Actigraphy will be collected nightly during treatment and at-home monitoring periods
Measured: 1 month
Change in wakefulness after sleep onset (WASO) as determined by actigraphy
Actigraphy will be collected nightly during treatment and at-home monitoring periods
Measured: 1 month
Change in in Psychomotor Vigilance Task (PVT) performance
PVT will be administered during pre and post MRI and before and after every treatment session.
Measured: 1 month
Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
RBANS will be administered during pre and post MRI days. The scale score ranges from 40-160, with 100 being the average. Higher scores indicate greater cognitive ability
Measured: 1 month
Changes in sleep as determined by self-report sleep diaries
Sleep diaries will be filled out daily during at-home monitoring and treatment periods. Questions about nightmares, sleep quality, naps, and wake-ups are recorded.
Measured: 1 month
Change in Spielberger State-Trait Anxiety Inventory (STAI)
Taken at pre and post MRI days and at both followups. State and trait scores result, ranging from 20-80 each. Higher scores indicate greater anxiety
Measured: 4 months
Change in Epworth Sleepiness Scale
Taken at both MRI days and at both followups. Total score ranging from 0-25 with higher scores indicating greater sleepiness.
Measured: 4 months
Change in Patient Health Questionnaire - 9 (PHQ-9)
Taken at screener, at pre and post MRI days, and at both followups. Scores ranging from 0-27 with higher scores indicating greater depression
Measured: 4 months
Change in Pittsburgh Sleep Quality Index
Taken at both MRI days and at both followups. Global score ranging from 0-78 and 7 component scores (sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction). Higher scores indicating greater sleep disturbances.
Measured: 4 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Scale
Taken at both MRI days and at both followups. Score ranging from 8-40 with higher scores indicating more impaired sleep
Measured: 4 months
Change in Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
Taken at both MRI days and at both followups. Score ranging from 8-40 with higher scores indicating more disturbed sleep
Measured: 4 months
Change in Morningness-Eveningness Questionnaire Type
Taken at both MRI days and at both followups. This scale classifies someone as definitely morning type, moderately morning type, neither type, moderately evening type, or definitely evening type.
Measured: 4 months
Change in Glasgow Content of Thoughts Inventory (GCTI) Scale Score
Taken at both MRI days and at both follow-ups. Score ranging from 25-100, with higher scores indicating more intrusive thoughts before sleep.
Measured: 4 months
Change in PTSD Checklist (PCL-5) Score
Taken at both MRI visits and at both follow-ups. Score ranging from 0-80, with higher scores indicating more severe reactions to PTSD
Measured: 4 months
Change in Positive and Negative Affect Schedule (PANAS) Scores
Taken at both MRI visits and followups. A score for positive and a score for negative affect, ranging from 10-50 each. Higher scores in either category indicate a greater amount of that kind of affect.
Measured: 4 months
Change in Nightmare Disorder Index Scores
Taken at both MRI days and at both follow-ups. Score ranging from 0-20 with greater scores indicating more severe nightmares.
Measured: 4 months
Change in Multidimensional Fatigue Inventory Scores
Taken at both MRI days and at both follow-ups. 5 dimensions of fatigue scores ranging from 4-20, one total score ranging from 20-100. Higher scores indicate greater fatigue
Measured: 4 months
Change in Mindful Attention Awareness Scale (MAAS) Score
Taken at both MRI visits and at both follow-ups. Mean score of all items ranging from 1-6, with higher scores indicating greater mindfulness.
Measured: 4 months
Change in Heart Rate Variability (HRV)
EKG will be taken at the physical and at both MRI visits. We will determine HRV based off of this data.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start23 Jun 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be 4 parallel groups of 30 participants, each receiving either one of the 3 possible stimulation sites or receiving placebo "Sham". The total number of subjects to be recruited locally to complete all study activities will be n=120. Due to prior experience with similar multi-day studies, it is expected that \~20% dropout before completion. Therefore, assuming this dropout rate (i.e., 24 consented participants), the plan is to enroll a total of 144 participants to achieve the final sample of 120 unable datasets.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research Acquisition Activity
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631209
- Sponsor's protocol ID
- STUDY00005073
- Status last verified
- Oct 2025
- First submitted
- 20 Sep 2024
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep - Clinical Trial
- ClinicalTrials.gov ID
- NCT06631209
- Acronym / sponsor ID
- STUDY00005073
- Conditions
- Insomnia
- Keywords
- Sleep Quality, Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research Acquisition Activity
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Phase 0: Screening and Rule-Outs:
During the REDCap Screening, participants will first read this informed consent form and sign it electronically on REDCap to proceed. To begin the screening questions, they must pass a 10-question comprehension check with questions regarding this document to ensure you understand the study. They will then answer a series of questionnaires related to demographics and health background. The REDCap screener will automatically end the survey if they indicate any exclusion. If you are included in the study, at the end of the screening questions it will indicate so and that we will be in contact with you shortly. They will then undergo a virtual psychological interview to determine if they indeed have Insomnia to qualify for the study. Then, they will be mailed WatchPAT monitoring equipment for them to utilize for one night of sleep monitoring at home. This device will measure their level of Obstructive Sleep Apnea, excluding them if they score \>15 AHI. We will review all of this data, and if they are eligible, participants will move on to Phase 1 of the study and undergo a second consent form.
Phase 1 In-Person Screening/Enrollment, Pre-Intervention:
Individuals who are eligible for this study after the three screening points will come into the lab to undergo an informational briefing and physical screening appointment. At this appointment, potential participants will complete the main consent for the rest of the study and get to ask any additional questions they have in person. Then, they will undergo a physical examination with a physician to determine eligibility. During the physical examination, there will be a collection of vital signs, EKG, and urine samples to screen for pregnancy and drugs (Ketamine, cocaine, MDMA, phenylcycline (PCP), and amphetamines). We will not be excluding for marijuana. In addition, individuals will complete evaluations to assess intelligence and cognition. If an individual is physically eligible and wishes to move forward, they will then be sent home and asked to complete 7 days of at-home sleep monitoring. This will include wearing an actigraph and a MUSE headband every night, while completing daily sleep diaries and short surveys every morning.
Phase-2 Baseline/Randomization/Active Intervention:
At the baseline visit participants will be asked to complete several cognitive and emotional assessments, have a pre-TMS neuroimaging scan and Electrocardiogram session, and undergo their first TMS administration. The first TMS administration will follow participant randomization into one of the four study conditions.
Following the baseline visit, during treatment participants will be asked to continue using the MUSE headband and actigraph every night and complete daily sleep diaries every morning. Participants will also be asked to return to the lab for 10 total TMS sessions in 2-3 weeks, all lasting around an hour in the evening. Participants will be administered a PVT task before and after each treatment session.
The kind of TMS we are administering is called Theta Burst Stimulation (TBS). A MagVenture MagPro X100 stimulator (MagVenture Inc. Denmark) connected with a figure-of-eight magnetic coil with active cooling will be used for the TBS protocol. Each individual is expected to have a different sensitivity to the magnetic fields generated by the cTBS, and the stimulation intensity will need to be adjusted based on each individual's resting motor threshold (RMT). Once we determine the RMT, we will set the machine to run at 70% of this level. The stimulation will last 40 seconds.
The ten TMS sessions will last for one hour between 6-9pm on weekdays. Ideally, there would be a session every weekday straight for two full weeks. We understand that this may be difficult for some people. If you need to miss a day or two, that is okay. However, 10 sessions are required. The maximum administration window is 3 weeks. The maximum number of days you can go between TMS sessions is 4 days. Please refrain from engaging in exercise in the time between your evening TMS session and when you go to bed.
Phase 3- Post-Intervention:
After participants complete the two-to-three-weeks of active intervention they will be asked to return to the lab to complete a post-intervention visit. This will involve the same testing as the pre-intervention (baseline) visit (MRI, surveys, and ECG). After this visit, participants will be sent home to continue recording sleep/activity for 7 more nights with the MUSE headband and actigraph, as well as continue recording sleep diaries and short surveys. This is the same as the at-home visit pre-intervention. After post-monitoring, participants will return to the lab for their final close-out visit. During this visit participants will return all study equipment and that will be the last of the in-person visits.
Phase 4- Follow-Up:
Participants who agree during the consent process will be contacted 1-month and 3-months after study completion to complete a series of brief assessments on REDCap, as well as another Psychological Interview at the 1-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- There will be 4 parallel groups of 30 participants, each receiving either one of the 3 possible stimulation sites or receiving placebo "Sham". The total number of subjects to be recruited locally to complete all study activities will be n=120. Due to prior experience with similar multi-day studies, it is expected that ~20% dropout before completion. Therefore, assuming this dropout rate (i.e., 24 consented participants), the plan is to enroll a total of 144 participants to achieve the final sample of 120 unable datasets.
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation - Posterior Cingulate Cortex | Active comparator | Device: Transcranial Magnetic Stimulation (TMS)Active Stimulation targeted at the Posterior Cingulate Cortex |
| Active Stimulation - Inferior Parietal Lobule | Active comparator | Device: Transcranial Magnetic Stimulation (TMS)Active Stimulation targeted at the Inferior Parietal Lobule |
| Active Stimulation - Dorsomedial Prefrontal Cortex | Active comparator | Device: Transcranial Magnetic Stimulation (TMS)Active Stimulation targeted at the Dorsomedial Prefrontal Cortex |
| Sham Stimulation | Sham comparator | Other: ShamThe TMS device will be placed to the head but no energy will be emitted. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS)Specifically, Continual Theta Burst Stimulation | Device | Active Stimulation - Dorsomedial Prefrontal Cortex, Active Stimulation - Inferior Parietal Lobule, Active Stimulation - Posterior Cingulate Cortex |
| ShamSham TMS | Other | Sham Stimulation |
Primary outcome
Sleep stage changes as determined by Polysomnography
Time frame: 1 month
PSG will be taken nightly during at home monitoring and treatment
Change in scores on the Pre-Sleep Arousal Scale (PSAS)
Time frame: 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) score
Time frame: 4 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 Polysomnography
Time frame: 1 month
PSG will be taken nightly during at home monitoring and treatment
Sleep efficiency change as determined by Polysomnography
Time frame: 1 month
PSG will be taken nightly during at home monitoring and treatment
Sleep latency change as determined by Polysomnography
Time frame: 1 month
PSG will be taken nightly during at home monitoring and treatment
Wakefulness after sleep onset (WASO) change as determined by Polysomnography
Time frame: 1 month
PSG will be taken nightly during at home monitoring and treatment
Change in DMN within-network connectivity during resting state
Time frame: 3 weeks
fMRI data will be collected during resting state in the scanner for pre and post
32 secondary outcomes
Change in DMN activity during a cognitively demanding task
Time frame: 1 week
Change in GABA levels in the posterior cingulate cortex
Time frame: 3 weeks
Change in glutamate/glutamine (glx) levels in the posterior cingulate cortex
Time frame: 3 weeks
Correlation between changes in GABA/glx levels and changes in resting state functional connectivity within the DMN
Time frame: 3 weeks
Correlation between changes in GABA/glx levels and changes in functional deactivation of the DMN during a cognitive challenge task
Time frame: 3 weeks
Change in lactate levels in the posterior cingulate cortex
Time frame: 3 weeks
Change in dynamic diffusion along the perivascular space
Time frame: 3 weeks
Change in scores on the Penn State Worry Questionnaire (PSWQ).
Time frame: 4 months
Change in scores on the Epsworth Sleepiness Scale (ESS)
Time frame: 4 months
Change in scores on the Functional Outcomes of Sleep Questionnaire (FOSQ)
Time frame: 4 months
Change in spectral density measure of the EEG beta1 and beta2 frequency bands with a focus on the frontal electrodes (Fp1, F7, F8)
Time frame: 1 month
Change in sleep duration determined by actigraphy
Time frame: 1 month
Change in sleep efficiency determined by actigraphy
Time frame: 1 month
Change in sleep latency determined by actigraphy
Time frame: 1 month
Change in wakefulness after sleep onset (WASO) as determined by actigraphy
Time frame: 1 month
Change in in Psychomotor Vigilance Task (PVT) performance
Time frame: 1 month
Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time frame: 1 month
Changes in sleep as determined by self-report sleep diaries
Time frame: 1 month
Change in Spielberger State-Trait Anxiety Inventory (STAI)
Time frame: 4 months
Change in Epworth Sleepiness Scale
Time frame: 4 months
Change in Patient Health Questionnaire - 9 (PHQ-9)
Time frame: 4 months
Change in Pittsburgh Sleep Quality Index
Time frame: 4 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Scale
Time frame: 4 months
Change in Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
Time frame: 4 months
Change in Morningness-Eveningness Questionnaire Type
Time frame: 4 months
Change in Glasgow Content of Thoughts Inventory (GCTI) Scale Score
Time frame: 4 months
Change in PTSD Checklist (PCL-5) Score
Time frame: 4 months
Change in Positive and Negative Affect Schedule (PANAS) Scores
Time frame: 4 months
Change in Nightmare Disorder Index Scores
Time frame: 4 months
Change in Multidimensional Fatigue Inventory Scores
Time frame: 4 months
Change in Mindful Attention Awareness Scale (MAAS) Score
Time frame: 4 months
Change in Heart Rate Variability (HRV)
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
Related trials for Insomnia
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (TMS) in people with Insomnia, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William Killgore, Ph.D. (520-621-0605, killgore@psychiatry.arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep stage changes as determined by Polysomnography (time frame: 1 month). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.