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NCT06631209 · ClinicalTrials.gov registry record · NA
Effectiveness of Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep - Clinical Trial
A NA study of Insomnia, sponsored by University of Arizona.
- Recruiting
- Registry status
- NA
- Development phase
- 144
- Enrollment target
- 1
- Study location
NCT06631209: Recruiting NA study of Insomnia, sponsored by University of Arizona.
NCT06631209 is a NA study of Insomnia that is actively recruiting participants, run by University of Arizona. The registered enrollment target is 144 participants, below the 169-participant average among 151 other Insomnia trials with a reported enrollment target (15% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06631209, a NA study of Insomnia, is actively recruiting participants, sponsored by University of Arizona.
- RECRUITING
- Registry status
- NA
- Development phase
- 144 participants
- Enrollment target
- 1
- Study location
Study 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. 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.
Primary Outcome
PSG will be taken nightly during at home monitoring and treatment
Conditions Studied
Interventions
- OTHER Sham
- DEVICE Transcranial Magnetic Stimulation (TMS)
Study Locations (1)
Arizona
- SCAN Lab - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2025-06-23 |
| Est. Completion | 2027-08 |
| Phase | NA |
What NCT06631209 shows while recruiting
NCT06631209 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 169-participant average among 151 other Insomnia trials with a reported enrollment target (15% lower).
The record links to 1 condition, with Insomnia appearing as the primary indexed condition, and to 2 interventions - of which Sham is the first listed.
NCT06631209 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT06631209 about?
NCT06631209 is a clinical study titled "Effectiveness of Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep - Clinical Trial". 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. Ther...
What is the current status of trial NCT06631209?
This trial is currently recruiting. It is a NA study. The enrollment target is 144 participants. The study started on 2025-06-23. Estimated completion is 2027-08.
What conditions does trial NCT06631209 study?
This clinical trial studies the following conditions: Insomnia.
What interventions are being tested in trial NCT06631209?
The interventions under investigation include: Sham (OTHER), Transcranial Magnetic Stimulation (TMS) (DEVICE).
Who is sponsoring clinical trial NCT06631209?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06631209 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Insomnia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06631209's enrollment target sits among peer trials
144 51st of 151 higher than 100 of 151 other Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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