Effectiveness of Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep - Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Sleep efficiency change as determined by Polysomnography
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Sleep efficiency change as determined by Polysomnography
时间窗: 1 month
PSG will be taken nightly during at home monitoring and treatment
Sleep latency change as determined by Polysomnography
时间窗: 1 month
PSG will be taken nightly during at home monitoring and treatment
Sleep stage changes as determined by Polysomnography
时间窗: 1 month
PSG will be taken nightly during at home monitoring and treatment
Change in scores on the Pre-Sleep Arousal Scale (PSAS)
时间窗: 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
时间窗: 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
时间窗: 1 month
PSG will be taken nightly during at home monitoring and treatment
Wakefulness after sleep onset (WASO) change as determined by Polysomnography
时间窗: 1 month
PSG will be taken nightly during at home monitoring and treatment
Change in DMN within-network connectivity during resting state
时间窗: 3 weeks
fMRI data will be collected during resting state in the scanner for pre and post
次要结局
- Change in DMN activity during a cognitively demanding task(1 week)
- Change in GABA levels in the posterior cingulate cortex(3 weeks)
- Change in glutamate/glutamine (glx) levels in the posterior cingulate cortex(3 weeks)
- Correlation between changes in GABA/glx levels and changes in resting state functional connectivity within the DMN(3 weeks)
- Correlation between changes in GABA/glx levels and changes in functional deactivation of the DMN during a cognitive challenge task(3 weeks)
- Change in lactate levels in the posterior cingulate cortex(3 weeks)
- Change in dynamic diffusion along the perivascular space(3 weeks)
- Change in scores on the Penn State Worry Questionnaire (PSWQ).(4 months)
- Change in scores on the Epsworth Sleepiness Scale (ESS)(4 months)
- Change in scores on the Functional Outcomes of Sleep Questionnaire (FOSQ)(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)(1 month)
- Change in sleep duration determined by actigraphy(1 month)
- Change in sleep efficiency determined by actigraphy(1 month)
- Change in sleep latency determined by actigraphy(1 month)
- Change in wakefulness after sleep onset (WASO) as determined by actigraphy(1 month)
- Change in in Psychomotor Vigilance Task (PVT) performance(1 month)
- Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)(1 month)
- Changes in sleep as determined by self-report sleep diaries(1 month)
- Change in Spielberger State-Trait Anxiety Inventory (STAI)(4 months)
- Change in Epworth Sleepiness Scale(4 months)
- Change in Patient Health Questionnaire - 9 (PHQ-9)(4 months)
- Change in Pittsburgh Sleep Quality Index(4 months)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Scale(4 months)
- Change in Patient-Reported Outcomes Measurement Information System - Sleep Disturbance(4 months)
- Change in Morningness-Eveningness Questionnaire Type(4 months)
- Change in Glasgow Content of Thoughts Inventory (GCTI) Scale Score(4 months)
- Change in PTSD Checklist (PCL-5) Score(4 months)
- Change in Positive and Negative Affect Schedule (PANAS) Scores(4 months)
- Change in Nightmare Disorder Index Scores(4 months)
- Change in Multidimensional Fatigue Inventory Scores(4 months)
- Change in Mindful Attention Awareness Scale (MAAS) Score(4 months)
- Change in Heart Rate Variability (HRV)(4 weeks)