Trial studying safety and effects for Insomnia
Official title Effectiveness of Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep - Clinical Trial
ClinicalTrials.gov ID: NCT06631209
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- Presence of any metal implant or medical device that may pose a safety risk for MRI or TMS (permanent hearing aids, cochlear implants, medication...
- Self-reported past or present medical diagnosis of sleep or breathing-related disorders such as sleep apnea other than insomnia (potential...
- 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...
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Tucson, Arizona, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Tucson, Arizona, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.