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Behavioural Intervention
Active cTBS for Primary Insomnia
N/A
Recruiting
Led By William D Killgore, PhD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately one hour after previous administration (2 hours after initial) during cognitive testing of overnight visit 1 (day 8-9), day 9
Awards & highlights
Study Summary
This study is evaluating whether a type of brain stimulation can improve sleep habits in healthy individuals.
Eligible Conditions
- Primary Insomnia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately one hour after previous administration during cognitive testing of overnight visit 1 (day 8-9), day 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately one hour after previous administration during cognitive testing of overnight visit 1 (day 8-9), day 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of time spent in each sleep stage following administration of active or sham cTBS TMS
Sleep efficiency (SE) following administration of active or sham cTBS TMS - day 8-9
Sleep onset latency (SOL) following administration of active or sham cTBS TMS
+8 moreSecondary outcome measures
Actigraphy
California Verbal Learning Test Third Edition (CVLT-3) - day 15-16
California Verbal Learning Test Third Edition (CVLT-3) - day 8-9
+83 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Sham cTBS first, then active cTBSExperimental Treatment2 Interventions
Participants complete an Enrollment Visit followed by one week of at-home actigraphy. Participants return to the lab for Overnight Visit 1 and undergo a MRI scan followed by sham cTBS and then another MRI scan followed by a night of polysomnographic monitored in-lab sleep. Participants return home and complete another week of at-home actigraphy. Participants then return to the lab for Overnight Visit 2 where they undergo a MRI scan followed by active cTBS and then another MRI scan followed by a night of polysomnographic monitored in-lab sleep.
Group II: Active cTBS first, then sham cTBSExperimental Treatment2 Interventions
Participants complete an Enrollment Visit followed by one week of at-home actigraphy. Participants return to the lab for Overnight Visit 1 and undergo a MRI scan followed by active cTBS and then another MRI scan followed by a night of polysomnographic monitored in-lab sleep. Participants return home and complete another week of at-home actigraphy. Participants then return to the lab for Overnight Visit 2 where they undergo a MRI scan followed by sham cTBS and then another MRI scan followed by a night of polysomnographic monitored in-lab sleep.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sham cTBS
2016
Completed Phase 2
~220
Find a Location
Who is running the clinical trial?
University of ArizonaLead Sponsor
516 Previous Clinical Trials
148,451 Total Patients Enrolled
William D Killgore, PhDPrincipal InvestigatorUniversity of Arizona
3 Previous Clinical Trials
150 Total Patients Enrolled
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